Government Intervenes in Heart Study Following Concerns About Underlying Research
FDA Injunctions Send Clear Message: Stem Cell Clinics Beware
Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?
Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?
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Company Wants to Bring the Dead Back to Life (No, Really)
Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says
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His public radio pieces have appeared on NPR, the World, Marketplace and the California Report.","avatar":"https://secure.gravatar.com/avatar/79417fe15fb540a8a1edb0aadefee19b?s=600&d=blank&r=g","twitter":null,"facebook":null,"instagram":null,"linkedin":null,"sites":[{"site":"news","roles":["subscriber"]},{"site":"futureofyou","roles":["author"]},{"site":"science","roles":["author"]},{"site":"quest","roles":["editor"]}],"headData":{"title":"David Gorn | KQED","description":"KQED Contributor","ogImgSrc":"https://secure.gravatar.com/avatar/79417fe15fb540a8a1edb0aadefee19b?s=600&d=blank&r=g","twImgSrc":"https://secure.gravatar.com/avatar/79417fe15fb540a8a1edb0aadefee19b?s=600&d=blank&r=g"},"isLoading":false,"link":"/author/dgorn"}},"breakingNewsReducer":{},"campaignFinanceReducer":{},"firebase":{"requesting":{},"requested":{},"timestamps":{},"data":{},"ordered":{},"auth":{"isLoaded":false,"isEmpty":true},"authError":null,"profile":{"isLoaded":false,"isEmpty":true},"listeners":{"byId":{},"allIds":[]},"isInitializing":false,"errors":[]},"navBarReducer":{"navBarId":"home","fullView":true,"showPlayer":false},"navMenuReducer":{"menus":[{"key":"menu1","items":[{"name":"News","link":"/","type":"title"},{"name":"Politics","link":"/politics"},{"name":"Science","link":"/science"},{"name":"Education","link":"/educationnews"},{"name":"Housing","link":"/housing"},{"name":"Immigration","link":"/immigration"},{"name":"Criminal Justice","link":"/criminaljustice"},{"name":"Silicon Valley","link":"/siliconvalley"},{"name":"Forum","link":"/forum"},{"name":"The California Report","link":"/californiareport"}]},{"key":"menu2","items":[{"name":"Arts & Culture","link":"/arts","type":"title"},{"name":"Critics’ Picks","link":"/thedolist"},{"name":"Cultural Commentary","link":"/artscommentary"},{"name":"Food & Drink","link":"/food"},{"name":"Bay Area Hip-Hop","link":"/bayareahiphop"},{"name":"Rebel Girls","link":"/rebelgirls"},{"name":"Arts Video","link":"/artsvideos"}]},{"key":"menu3","items":[{"name":"Podcasts","link":"/podcasts","type":"title"},{"name":"Bay Curious","link":"/podcasts/baycurious"},{"name":"Rightnowish","link":"/podcasts/rightnowish"},{"name":"The Bay","link":"/podcasts/thebay"},{"name":"On Our Watch","link":"/podcasts/onourwatch"},{"name":"Mindshift","link":"/podcasts/mindshift"},{"name":"Consider This","link":"/podcasts/considerthis"},{"name":"Political Breakdown","link":"/podcasts/politicalbreakdown"}]},{"key":"menu4","items":[{"name":"Live Radio","link":"/radio","type":"title"},{"name":"TV","link":"/tv","type":"title"},{"name":"Events","link":"/events","type":"title"},{"name":"For Educators","link":"/education","type":"title"},{"name":"Support KQED","link":"/support","type":"title"},{"name":"About","link":"/about","type":"title"},{"name":"Help Center","link":"https://kqed-helpcenter.kqed.org/s","type":"title"}]}]},"pagesReducer":{},"postsReducer":{"stream_live":{"type":"live","id":"stream_live","audioUrl":"https://streams.kqed.org/kqedradio","title":"Live Stream","excerpt":"Live Stream information currently unavailable.","link":"/radio","featImg":"","label":{"name":"KQED Live","link":"/"}},"stream_kqedNewscast":{"type":"posts","id":"stream_kqedNewscast","audioUrl":"https://www.kqed.org/.stream/anon/radio/RDnews/newscast.mp3?_=1","title":"KQED Newscast","featImg":"","label":{"name":"88.5 FM","link":"/"}},"futureofyou_445294":{"type":"posts","id":"futureofyou_445294","meta":{"index":"posts_1591205157","site":"futureofyou","id":"445294","score":null,"sort":[1540920607000]},"guestAuthors":[],"slug":"government-intervenes-in-heart-study-following-concerns-about-underlying-research","title":"Government Intervenes in Heart Study Following Concerns About Underlying Research","publishDate":1540920607,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp class=\"danger-zone\">A government agency has paused a clinical trial testing an experimental stem cell therapy in heart failure patients, a move made public on Monday and sparked by recommendations to retract 31 journal articles from the lab of a controversial cardiac stem cell researcher.[contextly_sidebar id=\"I7izVP7XTjOkvUPxO6DOfpUiStgsOB7A\"]\u003c/p>\n\u003cp class=\"danger-zone\">“Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial,” the \u003ca href=\"https://www.nih.gov/news-events/news-releases/statement-nhlbi-decision-pause-concert-hf-trial\" target=\"_blank\" rel=\"noopener\">National Heart, Lung, and Blood Institute\u003c/a> said in a statement posted Monday.\u003c/p>\n\u003cp class=\"danger-zone\">On Oct. 17, the \u003ca href=\"https://www.statnews.com/2018/10/17/nejm-retract-stem-cell-anversa/\">New England Journal of Medicine retracted\u003c/a> one paper and published an “expression of concern” about two others from the lab of Dr. Piero Anversa, a controversial stem cell researcher. The journal’s move came three days after Harvard Medical School and Brigham and Women’s Hospital told \u003ca href=\"https://www.statnews.com/2018/10/14/harvard-brigham-retractions-stem-cell/\">STAT and Retraction Watch\u003c/a> they had recommended that 31 papers from Anversa be retracted by medical journals.\u003c/p>\n\u003cp>Dr. David Goff, director of the Division of Cardiovascular Sciences at NHLBI, confirmed Monday that news about the 31 journal articles from the Anversa lab prompted the pause in the trial known as \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02501811\" target=\"_blank\" rel=\"noopener\">CONCERT-HF\u003c/a>. None of the retracted or disputed papers specifically relate to the trial\u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02501811\" target=\"_blank\" rel=\"noopener\">,\u003c/a> he said, but the trial’s Data and Safety Monitoring Board, convened last week at the institute’s request, on Friday recommended a “pause” in the trial so the board could complete its review.\u003c/p>\n\u003cp>Anversa’s research focused on advancing the idea that the heart contains stem cells, called c-kit cells, that could regenerate cardiac muscle after a heart attack. But when various research teams tried to reproduce results reported in his papers, they failed. Anversa left Harvard and the Brigham in 2015. Lawyers for Anversa and his colleague Dr. Annarosa Leri said earlier this month the doctors “stand by the scientific findings in their papers, including the existence and potential therapeutic benefits of cardiac stem cells.” In an Oct. 3 letter that Anversa provided to \u003ca href=\"https://www.nytimes.com/2018/10/29/health/dr-piero-anversa-harvard-retraction.html?action=click&module=Top%20Stories&pgtype=Homepage\" target=\"_blank\" rel=\"noopener\">The New York Times\u003c/a>, Harvard and the Brigham said he had “committed research misconduct” in eight papers and in a grant application.[contextly_sidebar id=\"J93WJNRRTNR70mMyZTyFDOqE9SKlEyHq\"]\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The CONCERT-HF study set out to determine whether c-kit+ cells, either alone or in combination with stem cells derived from the bone marrow, are safe and could help patients with chronic heart failure. There are limited treatment options for people with heart failure; half of them will die within five years of receiving a diagnosis.\u003c/p>\n\u003cp>Goff said that the study’s approval to launch in 2015 was based on 11 reports from eight different labs — all independent of Anversa’s — showing benefits from c-kit+ cells in animal experiments. At the time, reviewers of the study protocols were aware that other labs were unable to duplicate findings reported by Anversa and his colleagues.\u003c/p>\n\u003cp>The University of Texas and NHLBI are sponsors of the trial, which sought to enroll 141 patients at seven locations since it was launched in 2015. The trial has recruited 125 patients, Goff said. Of those 125 people, 117 have undergone tissue collection from bone marrow or heart muscle and 90 have been treated.\u003c/p>\n\u003cp>Dr. Lem Moye of the University of Texas said participants are being notified about the trial’s pause and being told that recent media coverage about cell therapy research is not directly related to CONCERT-HF.\u003c/p>\n\u003cp>“Although we do not follow the protocols of Dr. Anversa (we have our own lab at the University of Miami which uses GMP procedures, as is FDA approved). … NHLBI would like to assure itself that our lab is in fact generating c-kit+ cells,” Moye wrote in response to questions. “We hope that this will not take long.”\u003c/p>\n\u003cp>Goff said NHLBI has asked the board to conduct an “expeditious review in keeping with appropriate rigor.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“We have a responsibility to our participants and to generating knowledge to improve the health of people with heart failure.”\u003c/p>\n\n","blocks":[],"excerpt":"A trial testing experimental stem cell therapy in heart failure patients has been stalled following recommendations to retract 31 journal articles from the lab of a controversial researcher.","status":"publish","parent":0,"modified":1540920607,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":11,"wordCount":697},"headData":{"title":"Government Intervenes in Heart Study Following Concerns About Underlying Research | KQED","description":"A trial testing experimental stem cell therapy in heart failure patients has been stalled following recommendations to retract 31 journal articles from the lab of a controversial researcher.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Government Intervenes in Heart Study Following Concerns About Underlying Research","datePublished":"2018-10-30T17:30:07.000Z","dateModified":"2018-10-30T17:30:07.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"445294 https://ww2.kqed.org/futureofyou/?p=445294","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/10/30/government-intervenes-in-heart-study-following-concerns-about-underlying-research/","disqusTitle":"Government Intervenes in Heart Study Following Concerns About Underlying Research","source":"Health","nprByline":"Elizabeth Cooney\u003cbr />STAT","path":"/futureofyou/445294/government-intervenes-in-heart-study-following-concerns-about-underlying-research","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">A government agency has paused a clinical trial testing an experimental stem cell therapy in heart failure patients, a move made public on Monday and sparked by recommendations to retract 31 journal articles from the lab of a controversial cardiac stem cell researcher.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">“Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial,” the \u003ca href=\"https://www.nih.gov/news-events/news-releases/statement-nhlbi-decision-pause-concert-hf-trial\" target=\"_blank\" rel=\"noopener\">National Heart, Lung, and Blood Institute\u003c/a> said in a statement posted Monday.\u003c/p>\n\u003cp class=\"danger-zone\">On Oct. 17, the \u003ca href=\"https://www.statnews.com/2018/10/17/nejm-retract-stem-cell-anversa/\">New England Journal of Medicine retracted\u003c/a> one paper and published an “expression of concern” about two others from the lab of Dr. Piero Anversa, a controversial stem cell researcher. The journal’s move came three days after Harvard Medical School and Brigham and Women’s Hospital told \u003ca href=\"https://www.statnews.com/2018/10/14/harvard-brigham-retractions-stem-cell/\">STAT and Retraction Watch\u003c/a> they had recommended that 31 papers from Anversa be retracted by medical journals.\u003c/p>\n\u003cp>Dr. David Goff, director of the Division of Cardiovascular Sciences at NHLBI, confirmed Monday that news about the 31 journal articles from the Anversa lab prompted the pause in the trial known as \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02501811\" target=\"_blank\" rel=\"noopener\">CONCERT-HF\u003c/a>. None of the retracted or disputed papers specifically relate to the trial\u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02501811\" target=\"_blank\" rel=\"noopener\">,\u003c/a> he said, but the trial’s Data and Safety Monitoring Board, convened last week at the institute’s request, on Friday recommended a “pause” in the trial so the board could complete its review.\u003c/p>\n\u003cp>Anversa’s research focused on advancing the idea that the heart contains stem cells, called c-kit cells, that could regenerate cardiac muscle after a heart attack. But when various research teams tried to reproduce results reported in his papers, they failed. Anversa left Harvard and the Brigham in 2015. Lawyers for Anversa and his colleague Dr. Annarosa Leri said earlier this month the doctors “stand by the scientific findings in their papers, including the existence and potential therapeutic benefits of cardiac stem cells.” In an Oct. 3 letter that Anversa provided to \u003ca href=\"https://www.nytimes.com/2018/10/29/health/dr-piero-anversa-harvard-retraction.html?action=click&module=Top%20Stories&pgtype=Homepage\" target=\"_blank\" rel=\"noopener\">The New York Times\u003c/a>, Harvard and the Brigham said he had “committed research misconduct” in eight papers and in a grant application.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The CONCERT-HF study set out to determine whether c-kit+ cells, either alone or in combination with stem cells derived from the bone marrow, are safe and could help patients with chronic heart failure. There are limited treatment options for people with heart failure; half of them will die within five years of receiving a diagnosis.\u003c/p>\n\u003cp>Goff said that the study’s approval to launch in 2015 was based on 11 reports from eight different labs — all independent of Anversa’s — showing benefits from c-kit+ cells in animal experiments. At the time, reviewers of the study protocols were aware that other labs were unable to duplicate findings reported by Anversa and his colleagues.\u003c/p>\n\u003cp>The University of Texas and NHLBI are sponsors of the trial, which sought to enroll 141 patients at seven locations since it was launched in 2015. The trial has recruited 125 patients, Goff said. Of those 125 people, 117 have undergone tissue collection from bone marrow or heart muscle and 90 have been treated.\u003c/p>\n\u003cp>Dr. Lem Moye of the University of Texas said participants are being notified about the trial’s pause and being told that recent media coverage about cell therapy research is not directly related to CONCERT-HF.\u003c/p>\n\u003cp>“Although we do not follow the protocols of Dr. Anversa (we have our own lab at the University of Miami which uses GMP procedures, as is FDA approved). … NHLBI would like to assure itself that our lab is in fact generating c-kit+ cells,” Moye wrote in response to questions. “We hope that this will not take long.”\u003c/p>\n\u003cp>Goff said NHLBI has asked the board to conduct an “expeditious review in keeping with appropriate rigor.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“We have a responsibility to our participants and to generating knowledge to improve the health of people with heart failure.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/445294/government-intervenes-in-heart-study-following-concerns-about-underlying-research","authors":["byline_futureofyou_445294"],"categories":["futureofyou_73"],"tags":["futureofyou_1592","futureofyou_61","futureofyou_279","futureofyou_775","futureofyou_680"],"featImg":"futureofyou_445296","label":"source_futureofyou_445294"},"futureofyou_441482":{"type":"posts","id":"futureofyou_441482","meta":{"index":"posts_1591205157","site":"futureofyou","id":"441482","score":null,"sort":[1526009181000]},"guestAuthors":[],"slug":"fda-takes-action-against-california-stem-cell-clinics","title":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware","publishDate":1526009181,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>The Food and Drug Administration is getting serious about reining in stem cell clinics. On Wednesday, the agency \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm\" target=\"_blank\" rel=\"noopener\">announced\u003c/a> it wants to bar two of the largest clinic networks in the country from marketing their treatments, which would effectively halt their operations.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The clinic customers are really the guinea pigs here. And they’re paying [up to] $20,000 for that right to be a guinea pig.'\u003ccite>Paul Knoepfler, UC Davis\u003c/cite>\u003c/aside>\n\u003cp>At the FDA’s request, the Department of Justice will seek permanent injunctions to halt the core stem cell therapy used by U.S. Stem Cell Clinic of Sunshine, Florida, as well as the California Stem Cell Treatment Center and its affiliated Cell Surgical Network Corporation, located in Southern California. The two businesses\u003cb> \u003c/b>have affiliations with dozens of other stem cell clinics across the country, and the FDA said their method of stem cell therapy is unapproved, untested, and potentially dangerous for patients.\u003c/p>\n\u003cp>The request for the Florida injunction was prompted by four cases of blindness that occurred after patients received stem cell injections. In the filing against the California stem cell clinics, the FDA pointed to the use of smallpox vaccine to help create and use an unproven cancer therapy.\u003c/p>\n\u003cp>The agency’s action reflects its growing concern over the increase in stem cell clinics — an estimated 700 of them have popped up across the nation, with operations in almost every state.\u003c/p>\n\u003cp>Paul Knoepfler, a cell biology professor at UC Davis, is a stem cell researcher and one of the early critics of what he calls rogue stem cell clinics. These businesses leverage the power and hope resonant in the words “stem cell therapy,” while offering treatments that carry a big price tag and lack regulatory approval, he said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“The clinic customers are really the guinea pigs here,” Knoepfler said. “And they’re paying [up to] $20,000 for that right to be a guinea pig. These stem cells can do unexpected things, like grow tumors, or grow things where they’re not supposed to – like scar tissue inside someone’s eyeball.”\u003c/p>\n\u003cp>Many stem cell clinics promise cutting‐edge treatment for just about every malady imaginable, from impotence to autism to lymphoma to multiple sclerosis. To get stem cells for the treatment, many clinics suction off a patient’s belly fat, which contains stem cells, then create an extract of those cells to inject into other parts of the body. The theory is some of these cells might promote healing.\u003c/p>\n\u003cp>More traditional stem cell research has produced some impressive cures. But that process involves many levels of clinical trials and proof of efficacy before a treatment goes on the market, something stem cell clinics do not provide.\u003c/p>\n\u003cp>Knoepfler has compiled \u003ca href=\"http://www.cell.com/cms/attachment/2062931415/2065421495/mmc2.xlsx\">a list\u003c/a> of the roughly 700 clinics nationwide. “California is a hotspot state,” he said. “It’s the number one state. It has more than 100 clinics here.”\u003c/p>\n\u003cp>And the epicenter of that stem cell clinic activity is Southern California, and Beverly Hills in particular, which has 18 clinics, Knoepfler said.\u003c/p>\n\u003cp>The FDA began increasing oversight of stem cell clinics in August of last year, when it sent a warning letter to the U.S. Stem Cell Clinic in Florida, and at the same time asked U.S. marshals to conduct a raid on a company called StemImmune in San Diego, seizing vials of smallpox vaccine that were planned for use at two California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage.\u003c/p>\n\u003cp>And in November last year, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm\">released tightened rules\u003c/a> for stem cell clinics, making clear that fat-derived stem cell therapies would be classified as a drug and should be subject to FDA approval.\u003c/p>\n\u003cp>The stem cell clinic owners at the two targeted sites said they’ll vigorously fight the requested injunctions. Their argument is that people’s own cells cannot be classified as a drug or drug therapy, and that people should be allowed to use them in any way they want.\u003c/p>\n\u003cp>In a company statement, the Florida-based U.S. Stem Cell said it “believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.”\u003c/p>\n\u003cp>Knoepfler said the issue should not prompt a philosophical debate; it’s simply about patient safety.\u003c/p>\n\u003cp>“In theory the FDA can invoke criminal consequences, though we haven’t really seen that happen yet,” he said. “But with involvement of the Department of Justice in these particular cases with the injunctions, that to me seems a pretty serious indicator that this is something for stem cell clinics to take seriously.”\u003c/p>\n\u003cp>\u003cstrong>A Bigger Stick?\u003c/strong>\u003c/p>\n\u003cp>There is one more stick, yet to be wielded, that might be used to limit what therapies stem cell clinics can offer, and what claims they can make. The national Federation of State Medical Boards on May 8 released new\u003ca href=\"http://www.fsmb.org/globalassets/advocacy/policies/fsmb-stem-cell-workgroup-report.pdf\"> best-practices guidelines\u003c/a> for stem cell clinics. That’s significant because medical boards hold and can withdraw one of the things physicians value most: their medical license.\u003c/p>\n\u003cp>The recommendations are far-reaching: Medical boards can review and potentially withdraw licenses if stem cell clinics they are affiliated with make unsubstantiated claims, promote therapies not supported by science or use nondisclosure agreements to settle complaints.\u003c/p>\n\u003cp>Fines levied and court action taken by the FDA certainly can get people's attention, Knoepfler said, but the medical board federation's stance could be the real game-changer.\u003c/p>\n\u003cp>If doctors at stem cell clinics lose their medical license, it would cripple their credibility, impact their livelihood and potentially start an exodus of medical professionals out of the industry, he said.\u003c/p>\n\u003cp>“Somehow with the medical board license, for physicians it’s more of a tangible thing to take seriously,” Knoepfler said.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"Stem cell clinics have proliferated all over the country, and the FDA and stem cell experts say some of the treatments they peddle are dangerous.","status":"publish","parent":0,"modified":1526066880,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":1006},"headData":{"title":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware | KQED","description":"Stem cell clinics have proliferated all over the country, and the FDA and stem cell experts say some of the treatments they peddle are dangerous.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware","datePublished":"2018-05-11T03:26:21.000Z","dateModified":"2018-05-11T19:28:00.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"441482 https://ww2.kqed.org/futureofyou/?p=441482","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/05/10/fda-takes-action-against-california-stem-cell-clinics/","disqusTitle":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware","path":"/futureofyou/441482/fda-takes-action-against-california-stem-cell-clinics","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration is getting serious about reining in stem cell clinics. On Wednesday, the agency \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm\" target=\"_blank\" rel=\"noopener\">announced\u003c/a> it wants to bar two of the largest clinic networks in the country from marketing their treatments, which would effectively halt their operations.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The clinic customers are really the guinea pigs here. And they’re paying [up to] $20,000 for that right to be a guinea pig.'\u003ccite>Paul Knoepfler, UC Davis\u003c/cite>\u003c/aside>\n\u003cp>At the FDA’s request, the Department of Justice will seek permanent injunctions to halt the core stem cell therapy used by U.S. Stem Cell Clinic of Sunshine, Florida, as well as the California Stem Cell Treatment Center and its affiliated Cell Surgical Network Corporation, located in Southern California. The two businesses\u003cb> \u003c/b>have affiliations with dozens of other stem cell clinics across the country, and the FDA said their method of stem cell therapy is unapproved, untested, and potentially dangerous for patients.\u003c/p>\n\u003cp>The request for the Florida injunction was prompted by four cases of blindness that occurred after patients received stem cell injections. In the filing against the California stem cell clinics, the FDA pointed to the use of smallpox vaccine to help create and use an unproven cancer therapy.\u003c/p>\n\u003cp>The agency’s action reflects its growing concern over the increase in stem cell clinics — an estimated 700 of them have popped up across the nation, with operations in almost every state.\u003c/p>\n\u003cp>Paul Knoepfler, a cell biology professor at UC Davis, is a stem cell researcher and one of the early critics of what he calls rogue stem cell clinics. These businesses leverage the power and hope resonant in the words “stem cell therapy,” while offering treatments that carry a big price tag and lack regulatory approval, he said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“The clinic customers are really the guinea pigs here,” Knoepfler said. “And they’re paying [up to] $20,000 for that right to be a guinea pig. These stem cells can do unexpected things, like grow tumors, or grow things where they’re not supposed to – like scar tissue inside someone’s eyeball.”\u003c/p>\n\u003cp>Many stem cell clinics promise cutting‐edge treatment for just about every malady imaginable, from impotence to autism to lymphoma to multiple sclerosis. To get stem cells for the treatment, many clinics suction off a patient’s belly fat, which contains stem cells, then create an extract of those cells to inject into other parts of the body. The theory is some of these cells might promote healing.\u003c/p>\n\u003cp>More traditional stem cell research has produced some impressive cures. But that process involves many levels of clinical trials and proof of efficacy before a treatment goes on the market, something stem cell clinics do not provide.\u003c/p>\n\u003cp>Knoepfler has compiled \u003ca href=\"http://www.cell.com/cms/attachment/2062931415/2065421495/mmc2.xlsx\">a list\u003c/a> of the roughly 700 clinics nationwide. “California is a hotspot state,” he said. “It’s the number one state. It has more than 100 clinics here.”\u003c/p>\n\u003cp>And the epicenter of that stem cell clinic activity is Southern California, and Beverly Hills in particular, which has 18 clinics, Knoepfler said.\u003c/p>\n\u003cp>The FDA began increasing oversight of stem cell clinics in August of last year, when it sent a warning letter to the U.S. Stem Cell Clinic in Florida, and at the same time asked U.S. marshals to conduct a raid on a company called StemImmune in San Diego, seizing vials of smallpox vaccine that were planned for use at two California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage.\u003c/p>\n\u003cp>And in November last year, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm\">released tightened rules\u003c/a> for stem cell clinics, making clear that fat-derived stem cell therapies would be classified as a drug and should be subject to FDA approval.\u003c/p>\n\u003cp>The stem cell clinic owners at the two targeted sites said they’ll vigorously fight the requested injunctions. Their argument is that people’s own cells cannot be classified as a drug or drug therapy, and that people should be allowed to use them in any way they want.\u003c/p>\n\u003cp>In a company statement, the Florida-based U.S. Stem Cell said it “believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.”\u003c/p>\n\u003cp>Knoepfler said the issue should not prompt a philosophical debate; it’s simply about patient safety.\u003c/p>\n\u003cp>“In theory the FDA can invoke criminal consequences, though we haven’t really seen that happen yet,” he said. “But with involvement of the Department of Justice in these particular cases with the injunctions, that to me seems a pretty serious indicator that this is something for stem cell clinics to take seriously.”\u003c/p>\n\u003cp>\u003cstrong>A Bigger Stick?\u003c/strong>\u003c/p>\n\u003cp>There is one more stick, yet to be wielded, that might be used to limit what therapies stem cell clinics can offer, and what claims they can make. The national Federation of State Medical Boards on May 8 released new\u003ca href=\"http://www.fsmb.org/globalassets/advocacy/policies/fsmb-stem-cell-workgroup-report.pdf\"> best-practices guidelines\u003c/a> for stem cell clinics. That’s significant because medical boards hold and can withdraw one of the things physicians value most: their medical license.\u003c/p>\n\u003cp>The recommendations are far-reaching: Medical boards can review and potentially withdraw licenses if stem cell clinics they are affiliated with make unsubstantiated claims, promote therapies not supported by science or use nondisclosure agreements to settle complaints.\u003c/p>\n\u003cp>Fines levied and court action taken by the FDA certainly can get people's attention, Knoepfler said, but the medical board federation's stance could be the real game-changer.\u003c/p>\n\u003cp>If doctors at stem cell clinics lose their medical license, it would cripple their credibility, impact their livelihood and potentially start an exodus of medical professionals out of the industry, he said.\u003c/p>\n\u003cp>“Somehow with the medical board license, for physicians it’s more of a tangible thing to take seriously,” Knoepfler said.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/441482/fda-takes-action-against-california-stem-cell-clinics","authors":["8656"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1275","futureofyou_80","futureofyou_680"],"featImg":"futureofyou_262541","label":"futureofyou"},"futureofyou_438169":{"type":"posts","id":"futureofyou_438169","meta":{"index":"posts_1591205157","site":"futureofyou","id":"438169","score":null,"sort":[1516117527000]},"guestAuthors":[],"slug":"californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more","title":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?","publishDate":1516117527,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>The year was 2004, and great medical breakthroughs were supposedly right around the corner.\u003c/p>\n\u003cp>In TV advertisements, celebrities\u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\"> Michael J. Fox\u003c/a> and \u003ca href=\"https://preview-archives.nbclearn.com/portal/site/k-12/browse/?cuecard=4336\" target=\"_blank\" rel=\"noopener\">Christopher Reeve, \u003c/a>both suffering from incurable conditions, touted the promise of stem cell research, which could lead to a plethora of cures for life-threatening diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">Will California's appetite for funding stem cell research last?\u003c/aside>\n\u003cp>The ads ran in support of \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\" target=\"_blank\" rel=\"noopener\">Proposition 71\u003c/a>, a $3 billion California bond measure that would create the first state-funded stem cell agency in the nation. Three years earlier, the George W. Bush administration had \u003ca href=\"http://www.presidency.ucsb.edu/ws/?pid=79025\" target=\"_blank\" rel=\"noopener\">issued\u003c/a> rules to limit use of stem cells obtained from human embryos. But California voters easily passed Proposition 71, 59-41 percent. The California Institute for Regenerative Medicine, or \u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\">CIRM\u003c/a>, was born. Its mission: to fund and accelerate stem-cell-related treatments.\u003c/p>\n\u003cp>Fourteen years and billions of dollars later, the agency is running out of money, and backers of stem cell research \u003ca href=\"http://capitolweekly.net/stem-cell-agency-nears-5-billion-ballot-plan/\" target=\"_blank\" rel=\"noopener\">plan\u003c/a> on asking California voters to pony up for round two.\u003c/p>\n\u003cp>And those stem cell breakthroughs?\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Still right around the corner. Or, if you're an optimist, perhaps rounding it, now.\u003c/p>\n\u003caside class=\"alignright\">Promising but as yet unapproved therapies funded by CIRM\n\u003cul>\n\u003cli>Slowing or reversing \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">retinitis pigmentosa\u003c/a>\u003c/li>\n\u003cli>New shunt for \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">kidney dialysis patients\u003c/a>\u003c/li>\n\u003cli>Gene therapy for children with no \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">functioning immune system\u003c/a>\u003c/li>\n\u003cli>Help for \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/04/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says/\" target=\"_blank\" rel=\"noopener\">spinal-injury victims\u003c/a>\u003c/li>\n\u003cli>Lab-modified cells to treat \u003ca href=\"https://blog.cirm.ca.gov/2017/07/20/stem-cell-agency-funds-phase-3-clinical-trial-for-lou-gehrigs-disease/\" target=\"_blank\" rel=\"noopener\">ALS patients\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>\u003cstrong>The Pitch\u003c/strong>\u003c/p>\n\u003cp>Stem cell research proponents — including the same advocacy group that backed Proposition 71 — want to ask voters in the November 2020 election for $5 billion in bond money to continue the work of CIRM.\u003c/p>\n\u003cp>For voters, there will be one major question, according to Zev Yaroslavsky, an expert on state politics and government at UCLA.\u003c/p>\n\u003cp>“The public will want to know what they’ve gotten for their money.”\u003c/p>\n\u003cfigure id=\"attachment_188656\" class=\"wp-caption alignleft\" style=\"max-width: 351px\">\u003cimg class=\" wp-image-188656\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/StemCells-800x534.jpg\" alt=\"Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 at the Stem Cell Research Proposition Party at the Biltmore Hotel Nov. 2, 2004 in Los Angeles, California.\" width=\"351\" height=\"234\">\u003cfigcaption class=\"wp-caption-text\">Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 in 2004. \u003ccite>(Frazer Harrison/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Yaroslavsky expects to see plenty of funding measures on the 2020 ballot, including a parks bond and money for open space and schools, not to mention repeal of the gas tax.\u003c/p>\n\u003cp>“At what point do people start to vote no on everything?\" Yaroslavsky said. \"Or prioritize which of those many good causes they want to spend their money on?”\u003c/p>\n\u003cfigure id=\"attachment_262540\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-full wp-image-262540\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg\" alt=\"\" width=\"640\" height=\"588\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg 640w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons-400x368.jpg 400w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Human embryonic stem cells differentiating into neurons \u003ccite>(Guoping Fan/UCLA/CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Robert Klein, who spearheaded the original 2004 ballot measure and served as the CIRM board's first chairman, still heads the advocacy group, \u003ca href=\"https://americansforcures.org/\" target=\"_blank\" rel=\"noopener\">Americans for Cures\u003c/a>, that pushed Proposition 71. Medical science isn't exactly his field — he's president of a Palo Alto-based real estate development firm — but he got involved in stem cell funding because of his son's Type 1 diabetes, which is incurable.\u003c/p>\n\u003cp>Klein said re-funding the stem cell agency is not just a good cause, but good business.\u003c/p>\n\u003cp>“It has been a creator of jobs, and the state benefits from taxes by attracting research centers here,” he said.\u003c/p>\n\u003cp>[contextly_sidebar id=\"Bv07QyLXQ031CUEZCQOytRKusurX2p1i\"]A 2012 \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/about_cirm/Econ_Impact_REPORT_updated_2012.pdf\" target=\"_blank\" rel=\"noopener\">independent review\u003c/a> commissioned by CIRM and looking forward through 2014 estimated that its grants plus matching funds would result in an average of over 4,000 jobs created per year, and $205 million in state tax revenue.\u003c/p>\n\u003cp>As for the proposed new funding, Klein said the $5 billion bond cost would be amortized over 40 years, so it’s not a huge cost compared to other government projects.\u003c/p>\n\u003cp>“Look, we paid \u003ca href=\"https://www.citylab.com/equity/2015/10/from-250-million-to-65-billion-the-bay-bridge-cost-overrun/410254/\">$6.5 billion\u003c/a> just to fix the eastern span of the Bay Bridge,” Klein said. “That’s road infrastructure — this is more like [funding] the intellectual infrastructure of California.”\u003c/p>\n\u003cp>\u003cstrong>Where Are the Cures?\u003c/strong>\u003c/p>\n\u003cp>Stem cells are undifferentiated cells that can be transformed into specific tissue and organ cells. The 2004 ballot initiative struck an emotional chord, in part because of the high-profile cases of actors Reeve and Fox, who personified the hope that the cells could play a role in new therapies for incurable medical conditions. Reeve, who died in 2004, became a quadriplegic after injuring his spine in a horse-riding accident; Fox has Parkinson’s, a neurodegenerative disease.\u003c/p>\n\u003cp>In Fox's \u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\">30-second spot\u003c/a>, he used the word “cures” three times.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=fK9Eg0GVl7Q\u003c/p>\n\u003cp>So has CIRM produced any cures?\u003c/p>\n\u003cp>The family of 5-year-old \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">Evangelina Padilla-Vaccaro\u003c/a> would say yes.\u003c/p>\n\u003cp>Evangelina was born with a rare genetic condition called Severe Combined Immunodeficiency, or\u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/\" target=\"_blank\" rel=\"noopener\"> SCID\u003c/a>, also known as “bubble baby” disease. The ailment renders a patient's immune system nonfunctioning. The National Institutes of Health \u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/#al-3\" target=\"_blank\" rel=\"noopener\">estimates\u003c/a> approximately 40 to 100 children in the U.S. each year are diagnosed with the malady.\u003c/p>\n\u003cp>A team of UCLA clinical researchers, partially funded by CIRM, genetically modified Evangelina’s own blood stem cells to correct the SCID mutation.\u003c/p>\n\u003cp>She was cured.\u003c/p>\n\u003cp>Evangelina was the first to undergo the treatment, back when she was just a few months old. And now, CIRM says, at least 40 other children have been cured with the same procedure.\u003c/p>\n\u003cfigure id=\"attachment_438299\" class=\"wp-caption alignright\" style=\"max-width: 576px\">\u003cimg class=\"size-full wp-image-438299\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/evangelina_treatment.jpg\" alt=\"Baby in a hospital bed\" width=\"576\" height=\"768\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment.jpg 576w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-520x693.jpg 520w\" sizes=\"(max-width: 576px) 100vw, 576px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina being treated by Don Kohn and his team in 2012. \u003ccite>(UCLA)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Despite this success, the SCID trial is only in Phase 2. CIRM has only two trials in Phase 3, a necessary step before FDA approval: one testing a \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">new port\u003c/a> for kidney dialysis patients that is made out of human tissue and would not have to be replaced; and one that aims to\u003ca href=\"http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/07202017/phase-3-clinical-trial-targeting-lou-gehrigs-disease\" target=\"_blank\" rel=\"noopener\"> slow down\u003c/a> the progression of Lou Gehrig's disease.\u003c/p>\n\u003cp>Other promising CIRM-funded therapies include slowing or \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">reversing\u003c/a> retinitis pigmentosa, a genetic abnormality that destroys a person’s sight; and \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/26/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate/\" target=\"_blank\" rel=\"noopener\">injecting stem cells\u003c/a> into patients with severe spinal injuries.\u003c/p>\n\u003cp>The FDA has made several of these therapies eligible for priority review by granting them Regenerative Medicine Advanced Therapy, or \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm\" target=\"_blank\" rel=\"noopener\">RMAT\u003c/a>, status.\u003c/p>\n\u003cp>Clinical trials and research in less-advanced stages are ongoing for many other \u003ca href=\"https://www.cirm.ca.gov/grants\" target=\"_blank\" rel=\"noopener\">diseases and conditions\u003c/a>, including brain cancer, diabetes and HIV.\u003c/p>\n\u003cp>But the fact remains: Although this could change in the run-up to the election, no CIRM-funded stem cell treatment has yet to be approved by the FDA.\u003c/p>\n\u003cp>\u003cstrong>Miracles Capture the Imagination\u003c/strong>\u003c/p>\n\u003cp>Even outside of CIRM, only a handful of stem cell-related therapies have been approved for general use. Yet, stem cell research has captured the public's imagination with flashes of the miraculous.\u003c/p>\n\u003cfigure id=\"attachment_438300\" class=\"wp-caption alignright\" style=\"max-width: 594px\">\u003cimg class=\"size-full wp-image-438300\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/GettyImages-149183631.jpg\" alt=\"Middle aged man looks at camera.\" width=\"594\" height=\"396\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631.jpg 594w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-160x107.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-375x250.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-520x347.jpg 520w\" sizes=\"(max-width: 594px) 100vw, 594px\">\u003cfigcaption class=\"wp-caption-text\">Timothy Ray Brown, known as the 'Berlin patient' and the only person to have been cured of AIDS, at a press conference in 2012. \u003ccite>(T.J. Kirkpatrick/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Timothy Ray Brown, the famous \"\u003ca href=\"http://defeathiv.org/berlin/\" target=\"_blank\" rel=\"noopener\">Berlin patient\u003c/a>,\" for example, is an HIV patient who received a bone marrow transplant from a donor with a genetic mutation that endowed resistance to HIV. The transplant effectively cured Brown of the disease. However, there are currently a dearth of potential donors with the correct mutation, so researchers hope to create them, for use in patients' blood systems.\u003c/p>\n\u003cp>The bubble baby breakthrough and positive initial results in other CIRM-funded trials are strong selling points, said David Jensen, a journalist who covers stem cell research and writes a blog called \u003ca href=\"http://californiastemcellreport.blogspot.com/\" target=\"_blank\" rel=\"noopener\">California Stem Cell Report.\u003c/a>\u003c/p>\n\u003cp>\"There are some things CIRM can point to that are really impressive,\" Jensen said. \"It’s a pretty big deal in the world of science. It's the largest single source of funding for embryonic stem cell research in the world, and that’s no small thing.\"\u003c/p>\n\u003cp>[contextly_sidebar id=\"jHMWEkOPxg4IYTLSL83TfP2I7GjhjcyI\"]That doesn't necessarily mean voters will agree to re-fund it, he said.\u003c/p>\n\u003cp>Kevin McCormack, CIRM’s director of public communications and patient advocate outreach, said there's still time for CIRM to make a bigger splash.\u003c/p>\n\u003cp>“We’ve still got two more years,” McCormack said. “By 2020 I think people will see that CIRM-funded therapies are not just changing lives but saving lives.”\u003c/p>\n\u003cp>\u003cstrong>Overpromising: Something CIRM Has 'Had to Live With'\u003c/strong>\u003c/p>\n\u003cp>Klein, the backer of Proposition 71, said the 2004 campaign never promised cures during the lifetime of the stem cell agency, only progress toward attaining them.\u003c/p>\n\u003cp>“What we put in the ballot arguments is that we had to make major progress in mitigating disease, and moving toward cures,” Klein said. He feels that certainly has been achieved— and more. “In terms of progress toward the ultimate goal of cures, it’s remarkable what progress has been made.\u003c/p>\n\u003cp>\"When I look back, I think we have out-achieved the representations we put on the ballot.”\u003c/p>\n\u003cp>But even CIRM's McCormack has said, in an \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/22/stem-cells-where-science-hope-and-hype-meet/\" target=\"_blank\" rel=\"noopener\">interview with KQED\u003c/a> in 2016, that overpromising by the Proposition 71 campaign is \"something [CIRM] has had to live with.\"\u003c/p>\n\u003cp>Opposition during the \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\">first ballot measure\u003c/a> was based mostly on religious concerns about using embryonic stem cells, on the large amount of money (the $3 billion price tag actually costs taxpayers $6 billion when interest is included) and on the lack of any guarantees of specific achievements.\u003c/p>\n\u003cp>Jensen expects religious objections to resurface when the election campaigns ramp up — but that those might not gain traction, because the field has expanded into adult and \u003ca href=\"https://stemcell.ucla.edu/induced-pluripotent-stem-cells\" target=\"_blank\" rel=\"noopener\">induced pluripotent stem cells\u003c/a> in addition to embryonic cells.\u003c/p>\n\u003cfigure id=\"attachment_438301\" class=\"wp-caption alignleft\" style=\"max-width: 570px\">\u003cimg class=\"size-full wp-image-438301\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/cured_ar_2016_cover.png\" alt=\"\" width=\"570\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover.png 570w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-160x168.png 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-240x253.png 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-375x395.png 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-520x547.png 520w\" sizes=\"(max-width: 570px) 100vw, 570px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina Padilla-Vaccaro on the cover of CIRM's \u003ca href=\"https://www.cirm.ca.gov/about-cirm/cirm-annual-reports\">2016 Annual Report\u003c/a>. \u003ccite>(CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>And since the poster child for stem cell success could very well be the pint-sized and happy-faced Evangelina Padilla-Vaccaro, it may be hard to argue that these concerns outweigh not having to live in a bubble.\u003c/p>\n\u003cp>\"I mean, how can you be against that?\" Jensen said.\u003c/p>\n\u003cp>But some opposition has sprung up even inside the medical community. Barbara Koenig, head of the bioethics program at UCSF, pointed to ongoing concerns about conflict of interest at the agency — 90 percent of all spending benefited organizations that have been represented on the \u003ca href=\"https://www.cirm.ca.gov/board-and-meetings/list-icoc-members\" target=\"_blank\" rel=\"noopener\">governing board\u003c/a>, Jensen has been \u003ca href=\"http://capitolweekly.net/californias-stem-cell-agency-future-uncertain/\" target=\"_blank\" rel=\"noopener\">reporting\u003c/a>— and the public governance that she said has been lacking. (McCormack said the expansion of companies involved in stem cell research has resulted in broader distribution of funds. He also pointed to CIRM's adoption of more stringent\u003ca href=\"https://govt.westlaw.com/calregs/Document/ICD886A9181574C3BADD5946217E13F00?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.Default)&bhcp=1\" target=\"_blank\" rel=\"noopener\"> conflict-of-interest policies \u003c/a>in 2013.)\u003c/p>\n\u003caside class=\"pullquote alignright\">'I didn’t like the over-hyping of the immediate idea that [in 2004] there were cures around the corner. I think we need to be honest about how we’re investing in research.'\u003ccite>Barbara Koenig, UCSF bioethics program\u003cbr>\n\u003c/cite>\u003c/aside>\n\u003cp>Koenig supports stem cell research, but voted against the measure in 2004. And she has serious concerns about its possible renewal.\u003c/p>\n\u003cp>“I didn’t like the overhyping of the immediate idea that there were cures around the corner,” Koenig said. “I think we need to be honest about how we’re investing in research.”\u003c/p>\n\u003cp>Ask Koenig how she might use that proposed $5 billion differently, and she responds with a moment of stunned silence.\u003c/p>\n\u003cp>“Oh my, so many things,” she said. “I would try to figure out how to make sure every child in California has access to basic health services, nutrition, clean water . . . not just make high-priced products, but to improve public health.”\u003c/p>\n\u003cp>She said stem cell research \"privileges these quick-fix biotech approaches, which may make a lot of money but may not benefit the general public.”\u003c/p>\n\u003cp>Another bioethicist, Jodi Halpern of UC Berkeley, said the ballot initiative process is no place for a basic state spending decision.\u003c/p>\n\u003cp>“Why isn’t this a legislative issue?” Halpern asked. “We elect the Legislature to decide where California is going to spend its money. Putting this on the ballot, making it an emotional issue rather than just a financial one, that doesn’t sit right with me.\"\u003c/p>\n\u003cp>https://www.youtube.com/watch?time_continue=59&v=FjXiRx7DvzQ\u003c/p>\n\u003cp>\u003cstrong>Concerns vs. Cures\u003c/strong>\u003c/p>\n\u003cp>CIRM’s McCormack said he understands the concerns about state funding, but he said he's seen too much good come from the agency to see it wither on the budget-bickering vine.\u003c/p>\n\u003cp>“We are helping change the face of medicine,” he said. “We have so many clinical trials in the pipeline . . . that will pay off with therapies to help people who right now don’t have much of a chance for help, people with unmet medical needs.”\u003c/p>\n\u003cp>At its current spending pace, CIRM will run out of money by the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agedna_Item_%234_FINAL%20Dec%202017%20President%20Report%5B7%5D.pdf\" target=\"_blank\" rel=\"noopener\">end of 2019\u003c/a> — roughly a year before the proposed ballot measure vote. At its December 2017 board meeting, one of the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agenda_Item_%236_Presentation_Draft_1%5B2%5D_0.pdf\" target=\"_blank\" rel=\"noopener\">topics\u003c/a> for discussion was how to slow that spending and extend the agency’s grant-making till the end of 2020.\u003c/p>\n\u003cp>Board members and staffers aren’t involved in the proposed ballot measure, but they’re obviously keen on it, McCormack said.\u003c/p>\n\u003cp>Klein said he commissioned a survey to gauge interest and attitudes toward re-funding the agency. He said the numbers are strongly positive, but he has not released those results. There have been no other California polls on the topic since 2004, according to Jensen.\u003c/p>\n\u003cp>Even if voter attitudes are overwhelmingly favorable toward stem cell research, proponents may find that goodwill might wilt when it comes to passing a ballot measure, UCLA’s Yaroslavsky said.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“People do see stem cell research as something they have a stake in, but you’re going to have to explain what we got with the first $3 billion. I suspect their case with the voters will be that we need to keep momentum going. But the question is, 'Will they buy it?' ”\u003c/p>\n\n","blocks":[],"excerpt":"Fourteen years after Calif. voters approved $3 billion in funding to create a state stem cell agency, backers are planning to ask the public to pony up again. What achievements will they be able to point to?","status":"publish","parent":0,"modified":1516647437,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":67,"wordCount":2291},"headData":{"title":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More? | KQED","description":"Fourteen years after Calif. voters approved $3 billion in funding to create a state stem cell agency, backers are planning to ask the public to pony up again. What achievements will they be able to point to?","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?","datePublished":"2018-01-16T15:45:27.000Z","dateModified":"2018-01-22T18:57:17.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"438169 https://ww2.kqed.org/futureofyou/?p=438169","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/01/16/californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more/","disqusTitle":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?","source":"KQED Future of You","path":"/futureofyou/438169/californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The year was 2004, and great medical breakthroughs were supposedly right around the corner.\u003c/p>\n\u003cp>In TV advertisements, celebrities\u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\"> Michael J. Fox\u003c/a> and \u003ca href=\"https://preview-archives.nbclearn.com/portal/site/k-12/browse/?cuecard=4336\" target=\"_blank\" rel=\"noopener\">Christopher Reeve, \u003c/a>both suffering from incurable conditions, touted the promise of stem cell research, which could lead to a plethora of cures for life-threatening diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">Will California's appetite for funding stem cell research last?\u003c/aside>\n\u003cp>The ads ran in support of \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\" target=\"_blank\" rel=\"noopener\">Proposition 71\u003c/a>, a $3 billion California bond measure that would create the first state-funded stem cell agency in the nation. Three years earlier, the George W. Bush administration had \u003ca href=\"http://www.presidency.ucsb.edu/ws/?pid=79025\" target=\"_blank\" rel=\"noopener\">issued\u003c/a> rules to limit use of stem cells obtained from human embryos. But California voters easily passed Proposition 71, 59-41 percent. The California Institute for Regenerative Medicine, or \u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\">CIRM\u003c/a>, was born. Its mission: to fund and accelerate stem-cell-related treatments.\u003c/p>\n\u003cp>Fourteen years and billions of dollars later, the agency is running out of money, and backers of stem cell research \u003ca href=\"http://capitolweekly.net/stem-cell-agency-nears-5-billion-ballot-plan/\" target=\"_blank\" rel=\"noopener\">plan\u003c/a> on asking California voters to pony up for round two.\u003c/p>\n\u003cp>And those stem cell breakthroughs?\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Still right around the corner. Or, if you're an optimist, perhaps rounding it, now.\u003c/p>\n\u003caside class=\"alignright\">Promising but as yet unapproved therapies funded by CIRM\n\u003cul>\n\u003cli>Slowing or reversing \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">retinitis pigmentosa\u003c/a>\u003c/li>\n\u003cli>New shunt for \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">kidney dialysis patients\u003c/a>\u003c/li>\n\u003cli>Gene therapy for children with no \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">functioning immune system\u003c/a>\u003c/li>\n\u003cli>Help for \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/04/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says/\" target=\"_blank\" rel=\"noopener\">spinal-injury victims\u003c/a>\u003c/li>\n\u003cli>Lab-modified cells to treat \u003ca href=\"https://blog.cirm.ca.gov/2017/07/20/stem-cell-agency-funds-phase-3-clinical-trial-for-lou-gehrigs-disease/\" target=\"_blank\" rel=\"noopener\">ALS patients\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>\u003cstrong>The Pitch\u003c/strong>\u003c/p>\n\u003cp>Stem cell research proponents — including the same advocacy group that backed Proposition 71 — want to ask voters in the November 2020 election for $5 billion in bond money to continue the work of CIRM.\u003c/p>\n\u003cp>For voters, there will be one major question, according to Zev Yaroslavsky, an expert on state politics and government at UCLA.\u003c/p>\n\u003cp>“The public will want to know what they’ve gotten for their money.”\u003c/p>\n\u003cfigure id=\"attachment_188656\" class=\"wp-caption alignleft\" style=\"max-width: 351px\">\u003cimg class=\" wp-image-188656\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/StemCells-800x534.jpg\" alt=\"Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 at the Stem Cell Research Proposition Party at the Biltmore Hotel Nov. 2, 2004 in Los Angeles, California.\" width=\"351\" height=\"234\">\u003cfigcaption class=\"wp-caption-text\">Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 in 2004. \u003ccite>(Frazer Harrison/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Yaroslavsky expects to see plenty of funding measures on the 2020 ballot, including a parks bond and money for open space and schools, not to mention repeal of the gas tax.\u003c/p>\n\u003cp>“At what point do people start to vote no on everything?\" Yaroslavsky said. \"Or prioritize which of those many good causes they want to spend their money on?”\u003c/p>\n\u003cfigure id=\"attachment_262540\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-full wp-image-262540\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg\" alt=\"\" width=\"640\" height=\"588\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg 640w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons-400x368.jpg 400w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Human embryonic stem cells differentiating into neurons \u003ccite>(Guoping Fan/UCLA/CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Robert Klein, who spearheaded the original 2004 ballot measure and served as the CIRM board's first chairman, still heads the advocacy group, \u003ca href=\"https://americansforcures.org/\" target=\"_blank\" rel=\"noopener\">Americans for Cures\u003c/a>, that pushed Proposition 71. Medical science isn't exactly his field — he's president of a Palo Alto-based real estate development firm — but he got involved in stem cell funding because of his son's Type 1 diabetes, which is incurable.\u003c/p>\n\u003cp>Klein said re-funding the stem cell agency is not just a good cause, but good business.\u003c/p>\n\u003cp>“It has been a creator of jobs, and the state benefits from taxes by attracting research centers here,” he said.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>A 2012 \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/about_cirm/Econ_Impact_REPORT_updated_2012.pdf\" target=\"_blank\" rel=\"noopener\">independent review\u003c/a> commissioned by CIRM and looking forward through 2014 estimated that its grants plus matching funds would result in an average of over 4,000 jobs created per year, and $205 million in state tax revenue.\u003c/p>\n\u003cp>As for the proposed new funding, Klein said the $5 billion bond cost would be amortized over 40 years, so it’s not a huge cost compared to other government projects.\u003c/p>\n\u003cp>“Look, we paid \u003ca href=\"https://www.citylab.com/equity/2015/10/from-250-million-to-65-billion-the-bay-bridge-cost-overrun/410254/\">$6.5 billion\u003c/a> just to fix the eastern span of the Bay Bridge,” Klein said. “That’s road infrastructure — this is more like [funding] the intellectual infrastructure of California.”\u003c/p>\n\u003cp>\u003cstrong>Where Are the Cures?\u003c/strong>\u003c/p>\n\u003cp>Stem cells are undifferentiated cells that can be transformed into specific tissue and organ cells. The 2004 ballot initiative struck an emotional chord, in part because of the high-profile cases of actors Reeve and Fox, who personified the hope that the cells could play a role in new therapies for incurable medical conditions. Reeve, who died in 2004, became a quadriplegic after injuring his spine in a horse-riding accident; Fox has Parkinson’s, a neurodegenerative disease.\u003c/p>\n\u003cp>In Fox's \u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\">30-second spot\u003c/a>, he used the word “cures” three times.\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/fK9Eg0GVl7Q'\n title='//www.youtube.com/embed/fK9Eg0GVl7Q'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>So has CIRM produced any cures?\u003c/p>\n\u003cp>The family of 5-year-old \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">Evangelina Padilla-Vaccaro\u003c/a> would say yes.\u003c/p>\n\u003cp>Evangelina was born with a rare genetic condition called Severe Combined Immunodeficiency, or\u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/\" target=\"_blank\" rel=\"noopener\"> SCID\u003c/a>, also known as “bubble baby” disease. The ailment renders a patient's immune system nonfunctioning. The National Institutes of Health \u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/#al-3\" target=\"_blank\" rel=\"noopener\">estimates\u003c/a> approximately 40 to 100 children in the U.S. each year are diagnosed with the malady.\u003c/p>\n\u003cp>A team of UCLA clinical researchers, partially funded by CIRM, genetically modified Evangelina’s own blood stem cells to correct the SCID mutation.\u003c/p>\n\u003cp>She was cured.\u003c/p>\n\u003cp>Evangelina was the first to undergo the treatment, back when she was just a few months old. And now, CIRM says, at least 40 other children have been cured with the same procedure.\u003c/p>\n\u003cfigure id=\"attachment_438299\" class=\"wp-caption alignright\" style=\"max-width: 576px\">\u003cimg class=\"size-full wp-image-438299\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/evangelina_treatment.jpg\" alt=\"Baby in a hospital bed\" width=\"576\" height=\"768\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment.jpg 576w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-520x693.jpg 520w\" sizes=\"(max-width: 576px) 100vw, 576px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina being treated by Don Kohn and his team in 2012. \u003ccite>(UCLA)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Despite this success, the SCID trial is only in Phase 2. CIRM has only two trials in Phase 3, a necessary step before FDA approval: one testing a \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">new port\u003c/a> for kidney dialysis patients that is made out of human tissue and would not have to be replaced; and one that aims to\u003ca href=\"http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/07202017/phase-3-clinical-trial-targeting-lou-gehrigs-disease\" target=\"_blank\" rel=\"noopener\"> slow down\u003c/a> the progression of Lou Gehrig's disease.\u003c/p>\n\u003cp>Other promising CIRM-funded therapies include slowing or \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">reversing\u003c/a> retinitis pigmentosa, a genetic abnormality that destroys a person’s sight; and \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/26/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate/\" target=\"_blank\" rel=\"noopener\">injecting stem cells\u003c/a> into patients with severe spinal injuries.\u003c/p>\n\u003cp>The FDA has made several of these therapies eligible for priority review by granting them Regenerative Medicine Advanced Therapy, or \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm\" target=\"_blank\" rel=\"noopener\">RMAT\u003c/a>, status.\u003c/p>\n\u003cp>Clinical trials and research in less-advanced stages are ongoing for many other \u003ca href=\"https://www.cirm.ca.gov/grants\" target=\"_blank\" rel=\"noopener\">diseases and conditions\u003c/a>, including brain cancer, diabetes and HIV.\u003c/p>\n\u003cp>But the fact remains: Although this could change in the run-up to the election, no CIRM-funded stem cell treatment has yet to be approved by the FDA.\u003c/p>\n\u003cp>\u003cstrong>Miracles Capture the Imagination\u003c/strong>\u003c/p>\n\u003cp>Even outside of CIRM, only a handful of stem cell-related therapies have been approved for general use. Yet, stem cell research has captured the public's imagination with flashes of the miraculous.\u003c/p>\n\u003cfigure id=\"attachment_438300\" class=\"wp-caption alignright\" style=\"max-width: 594px\">\u003cimg class=\"size-full wp-image-438300\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/GettyImages-149183631.jpg\" alt=\"Middle aged man looks at camera.\" width=\"594\" height=\"396\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631.jpg 594w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-160x107.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-375x250.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-520x347.jpg 520w\" sizes=\"(max-width: 594px) 100vw, 594px\">\u003cfigcaption class=\"wp-caption-text\">Timothy Ray Brown, known as the 'Berlin patient' and the only person to have been cured of AIDS, at a press conference in 2012. \u003ccite>(T.J. Kirkpatrick/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Timothy Ray Brown, the famous \"\u003ca href=\"http://defeathiv.org/berlin/\" target=\"_blank\" rel=\"noopener\">Berlin patient\u003c/a>,\" for example, is an HIV patient who received a bone marrow transplant from a donor with a genetic mutation that endowed resistance to HIV. The transplant effectively cured Brown of the disease. However, there are currently a dearth of potential donors with the correct mutation, so researchers hope to create them, for use in patients' blood systems.\u003c/p>\n\u003cp>The bubble baby breakthrough and positive initial results in other CIRM-funded trials are strong selling points, said David Jensen, a journalist who covers stem cell research and writes a blog called \u003ca href=\"http://californiastemcellreport.blogspot.com/\" target=\"_blank\" rel=\"noopener\">California Stem Cell Report.\u003c/a>\u003c/p>\n\u003cp>\"There are some things CIRM can point to that are really impressive,\" Jensen said. \"It’s a pretty big deal in the world of science. It's the largest single source of funding for embryonic stem cell research in the world, and that’s no small thing.\"\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>That doesn't necessarily mean voters will agree to re-fund it, he said.\u003c/p>\n\u003cp>Kevin McCormack, CIRM’s director of public communications and patient advocate outreach, said there's still time for CIRM to make a bigger splash.\u003c/p>\n\u003cp>“We’ve still got two more years,” McCormack said. “By 2020 I think people will see that CIRM-funded therapies are not just changing lives but saving lives.”\u003c/p>\n\u003cp>\u003cstrong>Overpromising: Something CIRM Has 'Had to Live With'\u003c/strong>\u003c/p>\n\u003cp>Klein, the backer of Proposition 71, said the 2004 campaign never promised cures during the lifetime of the stem cell agency, only progress toward attaining them.\u003c/p>\n\u003cp>“What we put in the ballot arguments is that we had to make major progress in mitigating disease, and moving toward cures,” Klein said. He feels that certainly has been achieved— and more. “In terms of progress toward the ultimate goal of cures, it’s remarkable what progress has been made.\u003c/p>\n\u003cp>\"When I look back, I think we have out-achieved the representations we put on the ballot.”\u003c/p>\n\u003cp>But even CIRM's McCormack has said, in an \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/22/stem-cells-where-science-hope-and-hype-meet/\" target=\"_blank\" rel=\"noopener\">interview with KQED\u003c/a> in 2016, that overpromising by the Proposition 71 campaign is \"something [CIRM] has had to live with.\"\u003c/p>\n\u003cp>Opposition during the \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\">first ballot measure\u003c/a> was based mostly on religious concerns about using embryonic stem cells, on the large amount of money (the $3 billion price tag actually costs taxpayers $6 billion when interest is included) and on the lack of any guarantees of specific achievements.\u003c/p>\n\u003cp>Jensen expects religious objections to resurface when the election campaigns ramp up — but that those might not gain traction, because the field has expanded into adult and \u003ca href=\"https://stemcell.ucla.edu/induced-pluripotent-stem-cells\" target=\"_blank\" rel=\"noopener\">induced pluripotent stem cells\u003c/a> in addition to embryonic cells.\u003c/p>\n\u003cfigure id=\"attachment_438301\" class=\"wp-caption alignleft\" style=\"max-width: 570px\">\u003cimg class=\"size-full wp-image-438301\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/cured_ar_2016_cover.png\" alt=\"\" width=\"570\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover.png 570w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-160x168.png 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-240x253.png 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-375x395.png 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-520x547.png 520w\" sizes=\"(max-width: 570px) 100vw, 570px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina Padilla-Vaccaro on the cover of CIRM's \u003ca href=\"https://www.cirm.ca.gov/about-cirm/cirm-annual-reports\">2016 Annual Report\u003c/a>. \u003ccite>(CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>And since the poster child for stem cell success could very well be the pint-sized and happy-faced Evangelina Padilla-Vaccaro, it may be hard to argue that these concerns outweigh not having to live in a bubble.\u003c/p>\n\u003cp>\"I mean, how can you be against that?\" Jensen said.\u003c/p>\n\u003cp>But some opposition has sprung up even inside the medical community. Barbara Koenig, head of the bioethics program at UCSF, pointed to ongoing concerns about conflict of interest at the agency — 90 percent of all spending benefited organizations that have been represented on the \u003ca href=\"https://www.cirm.ca.gov/board-and-meetings/list-icoc-members\" target=\"_blank\" rel=\"noopener\">governing board\u003c/a>, Jensen has been \u003ca href=\"http://capitolweekly.net/californias-stem-cell-agency-future-uncertain/\" target=\"_blank\" rel=\"noopener\">reporting\u003c/a>— and the public governance that she said has been lacking. (McCormack said the expansion of companies involved in stem cell research has resulted in broader distribution of funds. He also pointed to CIRM's adoption of more stringent\u003ca href=\"https://govt.westlaw.com/calregs/Document/ICD886A9181574C3BADD5946217E13F00?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.Default)&bhcp=1\" target=\"_blank\" rel=\"noopener\"> conflict-of-interest policies \u003c/a>in 2013.)\u003c/p>\n\u003caside class=\"pullquote alignright\">'I didn’t like the over-hyping of the immediate idea that [in 2004] there were cures around the corner. I think we need to be honest about how we’re investing in research.'\u003ccite>Barbara Koenig, UCSF bioethics program\u003cbr>\n\u003c/cite>\u003c/aside>\n\u003cp>Koenig supports stem cell research, but voted against the measure in 2004. And she has serious concerns about its possible renewal.\u003c/p>\n\u003cp>“I didn’t like the overhyping of the immediate idea that there were cures around the corner,” Koenig said. “I think we need to be honest about how we’re investing in research.”\u003c/p>\n\u003cp>Ask Koenig how she might use that proposed $5 billion differently, and she responds with a moment of stunned silence.\u003c/p>\n\u003cp>“Oh my, so many things,” she said. “I would try to figure out how to make sure every child in California has access to basic health services, nutrition, clean water . . . not just make high-priced products, but to improve public health.”\u003c/p>\n\u003cp>She said stem cell research \"privileges these quick-fix biotech approaches, which may make a lot of money but may not benefit the general public.”\u003c/p>\n\u003cp>Another bioethicist, Jodi Halpern of UC Berkeley, said the ballot initiative process is no place for a basic state spending decision.\u003c/p>\n\u003cp>“Why isn’t this a legislative issue?” Halpern asked. “We elect the Legislature to decide where California is going to spend its money. Putting this on the ballot, making it an emotional issue rather than just a financial one, that doesn’t sit right with me.\"\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/FjXiRx7DvzQ'\n title='//www.youtube.com/embed/FjXiRx7DvzQ'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>\u003cstrong>Concerns vs. Cures\u003c/strong>\u003c/p>\n\u003cp>CIRM’s McCormack said he understands the concerns about state funding, but he said he's seen too much good come from the agency to see it wither on the budget-bickering vine.\u003c/p>\n\u003cp>“We are helping change the face of medicine,” he said. “We have so many clinical trials in the pipeline . . . that will pay off with therapies to help people who right now don’t have much of a chance for help, people with unmet medical needs.”\u003c/p>\n\u003cp>At its current spending pace, CIRM will run out of money by the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agedna_Item_%234_FINAL%20Dec%202017%20President%20Report%5B7%5D.pdf\" target=\"_blank\" rel=\"noopener\">end of 2019\u003c/a> — roughly a year before the proposed ballot measure vote. At its December 2017 board meeting, one of the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agenda_Item_%236_Presentation_Draft_1%5B2%5D_0.pdf\" target=\"_blank\" rel=\"noopener\">topics\u003c/a> for discussion was how to slow that spending and extend the agency’s grant-making till the end of 2020.\u003c/p>\n\u003cp>Board members and staffers aren’t involved in the proposed ballot measure, but they’re obviously keen on it, McCormack said.\u003c/p>\n\u003cp>Klein said he commissioned a survey to gauge interest and attitudes toward re-funding the agency. He said the numbers are strongly positive, but he has not released those results. There have been no other California polls on the topic since 2004, according to Jensen.\u003c/p>\n\u003cp>Even if voter attitudes are overwhelmingly favorable toward stem cell research, proponents may find that goodwill might wilt when it comes to passing a ballot measure, UCLA’s Yaroslavsky said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“People do see stem cell research as something they have a stake in, but you’re going to have to explain what we got with the first $3 billion. I suspect their case with the voters will be that we need to keep momentum going. But the question is, 'Will they buy it?' ”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/438169/californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more","authors":["8656"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_961","futureofyou_1275","futureofyou_80","futureofyou_680"],"featImg":"futureofyou_438308","label":"source_futureofyou_438169"},"futureofyou_436116":{"type":"posts","id":"futureofyou_436116","meta":{"index":"posts_1591205157","site":"futureofyou","id":"436116","score":null,"sort":[1509032630000]},"guestAuthors":[],"slug":"paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate","title":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?","publishDate":1509032630,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>If you've been reading about the\u003ca href=\"https://www.scistar-study.com/\" target=\"_blank\" rel=\"noopener\"> SCiStar\u003c/a> stem cell trial, you know the company's \u003ca href=\"http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3Chttp://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3E\" target=\"_blank\" rel=\"noopener\">reports\u003c/a> of its initial results sound truly remarkable.\u003c/p>\n\u003caside class=\"alignright\">All six paralyzed patients in Phase II of the SCiStar trial have regained some movement, and 4 out of 6 have made significant gains.\u003c/aside>\n\u003cp>The trial is injecting \u003ca href=\"https://en.wikipedia.org/wiki/Oligodendrocyte_progenitor_cell\" target=\"_blank\" rel=\"noopener\">oligodendrocyte progenitor cells\u003c/a>, produced from human embryonic stem cells, into patients ages 18-69. These trial subjects have suffered recent spinal cord injuries in the neck, resulting in the loss of nearly all sensation and movement below the injury, as well as some paralysis of the arms and legs.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">The results so far: One year after six people with severe spinal cord injuries received a dose of more than 10 million stem cells, all six patients have progressed at least one motor level on both sides of their bodies, based on a widely used \u003c/span>\u003cspan class=\"s1\">\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/\" target=\"_blank\" rel=\"noopener\">scale \u003c/a>\u003c/span>that measures the range of movement in various muscles.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">In addition, four of the patients jumped two levels on at least one side, and one patient advanced three. And two patients progressed two motor levels on both sides. \u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">This is all according to Asterias Biotherapeutics, the company conducting the trial. Asterias also says\u003c/span> patients in this cohort showed improvement between the six-month and 12-month marks from the time they received the infusion of stem cells.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial.'\u003ccite>Dr. Edward Wirth, Asterias Biotherapeutics\u003c/cite>\u003c/aside>\n\u003cp>“Usually what you see is a plateau, and that’s not what we’re seeing here. They continued to improve,” said Dr. Charles Liu, an investigator on the study and director of the USC Neurorestoration Center. “It was a durable effect. And that’s incredibly exciting.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cspan class=\"s1\">The trial is legitimate. It’s partially funded by the\u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\"> California Institute for Regenerative Medicine,\u003c/a> the state's stem cell agency; well-known spinal experts are participating; and the FDA has certified the treatment as one that preliminary clinical evidence indicates has the “potential to address unmet medical needs” related to a “serious or life-threatening disease or condition.” \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">There have also been a steady stream of media reports about the possibility of a breakthrough, including our own \u003ca href=\"https://ww2.kqed.org/futureofyou/tag/spinal-injuries/\" target=\"_blank\" rel=\"noopener\">coverage \u003c/a>and a recent \u003ca href=\"http://discovermagazine.com/2017/oct/what-once--was-lost\" target=\"_blank\" rel=\"noopener\">feature\u003c/a> by Discover magazine and front-page\u003ca href=\"http://www.sfchronicle.com/health/article/Super-exciting-results-in-stem-cell-therapy-12245199.php\" target=\"_blank\" rel=\"noopener\"> story \u003c/a>from the San Francisco Chronicle.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"'Super exciting' results in stem cell therapy trial,\" was the headline, quoting Dr. Edward Wirth, the chief medical officer at Asterias.\u003c/span>\u003c/p>\n\u003cp>\u003cstrong>It's Still Early\u003c/strong>\u003c/p>\n\u003cp>Regaining two motor levels in spinocervical patients is significant. That level of improvement could mean the difference between full paralysis from the neck down, requiring a ventilator to breathe, versus regaining some arm, hand and finger movement, enabling patients to take care of many of life’s daily tasks unassisted.\u003c/p>\n\u003cp>Below is video of Kris Boesen, a patient in the trial who at the age of 20 was paralyzed from the neck down.\u003c/p>\n\u003cp>\"I couldn't drink, I couldn't feed myself, I couldn't text or pretty much do anything,\" he says. \"I was basically just existing.\"\u003c/p>\n\u003cp>But after the stem cell treatment, he says, \"I'm able to live my life.\"\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=N0ZWqBWDoQI&ab_channel=AmericansforCures\u003c/p>\n\u003cp>Another trial patient, Lucas Lindner, was in a car accident that left him a quadriplegic, with no use of his hands or legs. After receiving the stem cells, he recovered to the point of being able to throw a ball, type and use a soldering gun.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=1DerDpM_FO4&ab_channel=AsteriasBiotherapeutics\u003c/p>\n\u003cp>These are compelling stories. And if the treatment really does work, it could provide hope to traumatic-injury patients who might otherwise show little progress or improvement in their paralysis.\u003c/p>\n\u003cp>But of course, the sample size we've seen so far is small — really small — just six patients. And it's true that some patients have been known to spontaneously recover some movement after spinal injuries without having received a cutting-edge stem cell treatment. Also, in this second phase of the trial, there is no control group. A double-blind, control-group study is planned in Phase III next year.\u003c/p>\n\u003caside class=\"pullquote alignright\">'As a scientist I think it’s very exciting.'\u003ccite>Oswald Steward, UC Irvine School of Medicine\u003c/cite>\u003c/aside>\n\u003cp>So we wondered, how can the people running the trial know, right now, that the level of improvement in their subjects is favorable to patients who haven't received the treatment, prompting such optimistic press releases? And how much excitement should anyone allow themselves over these early results?\u003c/p>\n\u003cp>\u003cstrong>Using Historical Data to Compare\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">The likelihood of all six patients recovering to the degree they have on their own is unlikely, researchers say.\u003c/p>\n\u003cp class=\"p1\">“This is as good as you could hope at this point,” said USC's Liu, in March. “So far all the evidence is pointing in the right direction.\"\u003c/p>\n\u003cp>Asterias, based in Fremont, Calif., has tried to assess these early results by comparing the improvement in its cohort of patients to historical data from an estimated pool of 3,300 spinal injury victims in the \u003ca href=\"https://www.emsci.org/\" target=\"_blank\" rel=\"noopener\">European Multicenter Study about Spinal Cord Injury\u003c/a>. Asterias says the level of progress for its six subjects is about twice the rate of recovery patients saw in the European data, dating back to 2001.\u003c/p>\n\u003cp>\"The 12-month data showed 67% (4/6) of Cohort 2 (subjects) have recovered 2 or more motor levels on at least one side through 12 months, which is more than double the rates of recovery seen in both matched historical controls and published data in a similar population,\" the company wrote in an October \u003ca href=\"http://www.asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program\" target=\"_blank\" rel=\"noopener\">press release\u003c/a>.\u003c/p>\n\u003cp>But according to Oswald Steward, director of the Reeve-Irvine spinal cord research center at the UC Irvine School of Medicine, there are so many variables to be considered when you look at historical data, you really have to take any conclusions with a few grains of salt.\u003c/p>\n\u003cp>“It sounds good, but it’s not a control group, there’s no real data here,\" Steward says. \"It’s nice to give some background, to give you a sense of [comparative recovery rates], but that’s definitely the way I would put it.\"\u003c/p>\n\u003cp>Getting background information to give a rough framework of comparison is exactly what the company wanted to accomplish, according to \u003cspan class=\"s1\">Wirth, Asterias' chief medical officer.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial,\" he says. \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">That's the plan in Phase\u003cstrong> \u003c/strong>III of the trial. \u003c/span>\u003cspan class=\"s1\">\"The historical controls are merely a temporary comparator to help us determine whether the ... program should move forward.\"\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">\u003cstrong>An Unusual Step\u003c/strong>\u003c/span>\u003c/p>\n\u003cp>Historical data is often used in cancer studies because of the fixed nature of outcomes in some cancer types, but it's unusual to see early-stage clinical trials in other areas use it as a comparison, says Karen Messer, chief of the Biostatistics and Bioinformatics division at the Moores Cancer Center at UC San Diego Health.\u003c/p>\n\u003cp>“Use of historical controls is common in early-phase cancer studies because they usually have small sample sizes and the end points are really well-defined,\" she says.\u003c/p>\n\u003cp>But spinal cord injury outcomes may be more varied, Messer says, so the results of an intervention wouldn't be as reliable.\u003c/p>\n\u003cp>“(T)here are a few things to watch for: Are the patients comparable? Has treatment changed? You want to make sure the response assessment is not subject to any judgment calls.”\u003c/p>\n\u003cp>Asterias mined the European historical data because it was the only large spinal-injury database with current information that could be licensed, Wirth said in an internal memo on the rationale and methods for compiling historical data.\u003c/p>\n\u003cp>In that memo, Wirth wrote that some variables are not included in the European database. These include MRI data on spinal cord lesions and the timing or quality of decompression, a bone-trimming surgery that makes more room for nerves. These differences in the data make direct comparisons harder.\u003c/p>\n\u003cp>Diana Miglioretti is a biostatistics professor at UC Davis. She says historical data is an interesting approach to frame a comparison.\u003c/p>\n\u003cp>“Obviously it isn’t as strong as a control group,” she says, “but if there aren’t major time trends, it can be a reasonable alternative.”\u003c/p>\n\u003cp>In other words, Miglioretti says, if outcomes haven't changed over time — due to improvements in treatment, for example — it's not out of the question that historical data can serve as a control.\u003c/p>\n\u003cp>But according to spinal cord researcher Steward, that’s the main concern about taking historical data on spinal injuries at face value .\u003c/p>\n\u003cp>“In the past we treated spinal injury differently,” Steward says. “For instance the amount of time people spend in rehab is a lot less than it was 10 years ago.”\u003c/p>\n\u003cp>\u003cstrong>Strong Anecdotal Statements\u003c/strong>\u003c/p>\n\u003cp>From Steward’s point of view, the real reason to get excited about the phenomenal initial results of this stem cell therapy is not the supporting historical data, but rather the anecdotal statements by the clinical researchers.\u003c/p>\n\u003cp>For instance, he points to the statements by Richard Fessler, the lead investigator of the Asterias trial and a professor of neurosurgery at Rush University Medical Center in Chicago. “I’ve been treating these kinds of patients for 30 years,” Fessler said in the San Francisco Chronicle story, “and I’ve never seen anything like this before.” (Fessler has no financial stake in Asterias, company officials say.)\u003c/p>\n\u003cp>“When someone like Fessler says 'I’ve never seen anything like that,' ” Steward says, “I spend more time listening to that than to historical data.”\u003c/p>\n\u003cp>Steward also points out that this stem cell therapy won’t help those with chronic spinal injuries, but says it could be a game-changer for newly injured patients.\u003c/p>\n\u003cp>“Still, this is huge,” he says. “Things are progressing in a positive way. No bad outcomes, and people seem to be improving in a way that may be unprecedented. As a scientist I think it’s very exciting.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Jon Brooks contributed to this report.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"A year after six patients with severe spinal cord injuries received a dose of 10 million stem cells, all six have progressed at least one motor level on both sides of their bodies. A closer look at the evidence ...","status":"publish","parent":0,"modified":1509400539,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":43,"wordCount":1744},"headData":{"title":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate? | KQED","description":"A year after six patients with severe spinal cord injuries received a dose of 10 million stem cells, all six have progressed at least one motor level on both sides of their bodies. A closer look at the evidence ...","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?","datePublished":"2017-10-26T15:43:50.000Z","dateModified":"2017-10-30T21:55:39.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"436116 https://ww2.kqed.org/futureofyou/?p=436116","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/10/26/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate/","disqusTitle":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?","source":"Future of You","nprByline":"David Gorn\u003cbr />Future of You","path":"/futureofyou/436116/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>If you've been reading about the\u003ca href=\"https://www.scistar-study.com/\" target=\"_blank\" rel=\"noopener\"> SCiStar\u003c/a> stem cell trial, you know the company's \u003ca href=\"http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3Chttp://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3E\" target=\"_blank\" rel=\"noopener\">reports\u003c/a> of its initial results sound truly remarkable.\u003c/p>\n\u003caside class=\"alignright\">All six paralyzed patients in Phase II of the SCiStar trial have regained some movement, and 4 out of 6 have made significant gains.\u003c/aside>\n\u003cp>The trial is injecting \u003ca href=\"https://en.wikipedia.org/wiki/Oligodendrocyte_progenitor_cell\" target=\"_blank\" rel=\"noopener\">oligodendrocyte progenitor cells\u003c/a>, produced from human embryonic stem cells, into patients ages 18-69. These trial subjects have suffered recent spinal cord injuries in the neck, resulting in the loss of nearly all sensation and movement below the injury, as well as some paralysis of the arms and legs.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">The results so far: One year after six people with severe spinal cord injuries received a dose of more than 10 million stem cells, all six patients have progressed at least one motor level on both sides of their bodies, based on a widely used \u003c/span>\u003cspan class=\"s1\">\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/\" target=\"_blank\" rel=\"noopener\">scale \u003c/a>\u003c/span>that measures the range of movement in various muscles.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">In addition, four of the patients jumped two levels on at least one side, and one patient advanced three. And two patients progressed two motor levels on both sides. \u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">This is all according to Asterias Biotherapeutics, the company conducting the trial. Asterias also says\u003c/span> patients in this cohort showed improvement between the six-month and 12-month marks from the time they received the infusion of stem cells.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial.'\u003ccite>Dr. Edward Wirth, Asterias Biotherapeutics\u003c/cite>\u003c/aside>\n\u003cp>“Usually what you see is a plateau, and that’s not what we’re seeing here. They continued to improve,” said Dr. Charles Liu, an investigator on the study and director of the USC Neurorestoration Center. “It was a durable effect. And that’s incredibly exciting.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">The trial is legitimate. It’s partially funded by the\u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\"> California Institute for Regenerative Medicine,\u003c/a> the state's stem cell agency; well-known spinal experts are participating; and the FDA has certified the treatment as one that preliminary clinical evidence indicates has the “potential to address unmet medical needs” related to a “serious or life-threatening disease or condition.” \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">There have also been a steady stream of media reports about the possibility of a breakthrough, including our own \u003ca href=\"https://ww2.kqed.org/futureofyou/tag/spinal-injuries/\" target=\"_blank\" rel=\"noopener\">coverage \u003c/a>and a recent \u003ca href=\"http://discovermagazine.com/2017/oct/what-once--was-lost\" target=\"_blank\" rel=\"noopener\">feature\u003c/a> by Discover magazine and front-page\u003ca href=\"http://www.sfchronicle.com/health/article/Super-exciting-results-in-stem-cell-therapy-12245199.php\" target=\"_blank\" rel=\"noopener\"> story \u003c/a>from the San Francisco Chronicle.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"'Super exciting' results in stem cell therapy trial,\" was the headline, quoting Dr. Edward Wirth, the chief medical officer at Asterias.\u003c/span>\u003c/p>\n\u003cp>\u003cstrong>It's Still Early\u003c/strong>\u003c/p>\n\u003cp>Regaining two motor levels in spinocervical patients is significant. That level of improvement could mean the difference between full paralysis from the neck down, requiring a ventilator to breathe, versus regaining some arm, hand and finger movement, enabling patients to take care of many of life’s daily tasks unassisted.\u003c/p>\n\u003cp>Below is video of Kris Boesen, a patient in the trial who at the age of 20 was paralyzed from the neck down.\u003c/p>\n\u003cp>\"I couldn't drink, I couldn't feed myself, I couldn't text or pretty much do anything,\" he says. \"I was basically just existing.\"\u003c/p>\n\u003cp>But after the stem cell treatment, he says, \"I'm able to live my life.\"\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/N0ZWqBWDoQI'\n title='//www.youtube.com/embed/N0ZWqBWDoQI'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Another trial patient, Lucas Lindner, was in a car accident that left him a quadriplegic, with no use of his hands or legs. After receiving the stem cells, he recovered to the point of being able to throw a ball, type and use a soldering gun.\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/1DerDpM_FO4'\n title='//www.youtube.com/embed/1DerDpM_FO4'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>These are compelling stories. And if the treatment really does work, it could provide hope to traumatic-injury patients who might otherwise show little progress or improvement in their paralysis.\u003c/p>\n\u003cp>But of course, the sample size we've seen so far is small — really small — just six patients. And it's true that some patients have been known to spontaneously recover some movement after spinal injuries without having received a cutting-edge stem cell treatment. Also, in this second phase of the trial, there is no control group. A double-blind, control-group study is planned in Phase III next year.\u003c/p>\n\u003caside class=\"pullquote alignright\">'As a scientist I think it’s very exciting.'\u003ccite>Oswald Steward, UC Irvine School of Medicine\u003c/cite>\u003c/aside>\n\u003cp>So we wondered, how can the people running the trial know, right now, that the level of improvement in their subjects is favorable to patients who haven't received the treatment, prompting such optimistic press releases? And how much excitement should anyone allow themselves over these early results?\u003c/p>\n\u003cp>\u003cstrong>Using Historical Data to Compare\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">The likelihood of all six patients recovering to the degree they have on their own is unlikely, researchers say.\u003c/p>\n\u003cp class=\"p1\">“This is as good as you could hope at this point,” said USC's Liu, in March. “So far all the evidence is pointing in the right direction.\"\u003c/p>\n\u003cp>Asterias, based in Fremont, Calif., has tried to assess these early results by comparing the improvement in its cohort of patients to historical data from an estimated pool of 3,300 spinal injury victims in the \u003ca href=\"https://www.emsci.org/\" target=\"_blank\" rel=\"noopener\">European Multicenter Study about Spinal Cord Injury\u003c/a>. Asterias says the level of progress for its six subjects is about twice the rate of recovery patients saw in the European data, dating back to 2001.\u003c/p>\n\u003cp>\"The 12-month data showed 67% (4/6) of Cohort 2 (subjects) have recovered 2 or more motor levels on at least one side through 12 months, which is more than double the rates of recovery seen in both matched historical controls and published data in a similar population,\" the company wrote in an October \u003ca href=\"http://www.asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program\" target=\"_blank\" rel=\"noopener\">press release\u003c/a>.\u003c/p>\n\u003cp>But according to Oswald Steward, director of the Reeve-Irvine spinal cord research center at the UC Irvine School of Medicine, there are so many variables to be considered when you look at historical data, you really have to take any conclusions with a few grains of salt.\u003c/p>\n\u003cp>“It sounds good, but it’s not a control group, there’s no real data here,\" Steward says. \"It’s nice to give some background, to give you a sense of [comparative recovery rates], but that’s definitely the way I would put it.\"\u003c/p>\n\u003cp>Getting background information to give a rough framework of comparison is exactly what the company wanted to accomplish, according to \u003cspan class=\"s1\">Wirth, Asterias' chief medical officer.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial,\" he says. \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">That's the plan in Phase\u003cstrong> \u003c/strong>III of the trial. \u003c/span>\u003cspan class=\"s1\">\"The historical controls are merely a temporary comparator to help us determine whether the ... program should move forward.\"\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">\u003cstrong>An Unusual Step\u003c/strong>\u003c/span>\u003c/p>\n\u003cp>Historical data is often used in cancer studies because of the fixed nature of outcomes in some cancer types, but it's unusual to see early-stage clinical trials in other areas use it as a comparison, says Karen Messer, chief of the Biostatistics and Bioinformatics division at the Moores Cancer Center at UC San Diego Health.\u003c/p>\n\u003cp>“Use of historical controls is common in early-phase cancer studies because they usually have small sample sizes and the end points are really well-defined,\" she says.\u003c/p>\n\u003cp>But spinal cord injury outcomes may be more varied, Messer says, so the results of an intervention wouldn't be as reliable.\u003c/p>\n\u003cp>“(T)here are a few things to watch for: Are the patients comparable? Has treatment changed? You want to make sure the response assessment is not subject to any judgment calls.”\u003c/p>\n\u003cp>Asterias mined the European historical data because it was the only large spinal-injury database with current information that could be licensed, Wirth said in an internal memo on the rationale and methods for compiling historical data.\u003c/p>\n\u003cp>In that memo, Wirth wrote that some variables are not included in the European database. These include MRI data on spinal cord lesions and the timing or quality of decompression, a bone-trimming surgery that makes more room for nerves. These differences in the data make direct comparisons harder.\u003c/p>\n\u003cp>Diana Miglioretti is a biostatistics professor at UC Davis. She says historical data is an interesting approach to frame a comparison.\u003c/p>\n\u003cp>“Obviously it isn’t as strong as a control group,” she says, “but if there aren’t major time trends, it can be a reasonable alternative.”\u003c/p>\n\u003cp>In other words, Miglioretti says, if outcomes haven't changed over time — due to improvements in treatment, for example — it's not out of the question that historical data can serve as a control.\u003c/p>\n\u003cp>But according to spinal cord researcher Steward, that’s the main concern about taking historical data on spinal injuries at face value .\u003c/p>\n\u003cp>“In the past we treated spinal injury differently,” Steward says. “For instance the amount of time people spend in rehab is a lot less than it was 10 years ago.”\u003c/p>\n\u003cp>\u003cstrong>Strong Anecdotal Statements\u003c/strong>\u003c/p>\n\u003cp>From Steward’s point of view, the real reason to get excited about the phenomenal initial results of this stem cell therapy is not the supporting historical data, but rather the anecdotal statements by the clinical researchers.\u003c/p>\n\u003cp>For instance, he points to the statements by Richard Fessler, the lead investigator of the Asterias trial and a professor of neurosurgery at Rush University Medical Center in Chicago. “I’ve been treating these kinds of patients for 30 years,” Fessler said in the San Francisco Chronicle story, “and I’ve never seen anything like this before.” (Fessler has no financial stake in Asterias, company officials say.)\u003c/p>\n\u003cp>“When someone like Fessler says 'I’ve never seen anything like that,' ” Steward says, “I spend more time listening to that than to historical data.”\u003c/p>\n\u003cp>Steward also points out that this stem cell therapy won’t help those with chronic spinal injuries, but says it could be a game-changer for newly injured patients.\u003c/p>\n\u003cp>“Still, this is huge,” he says. “Things are progressing in a positive way. No bad outcomes, and people seem to be improving in a way that may be unprecedented. As a scientist I think it’s very exciting.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Jon Brooks contributed to this report.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/436116/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate","authors":["byline_futureofyou_436116"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1367","futureofyou_1222","futureofyou_1010","futureofyou_680"],"featImg":"futureofyou_436440","label":"source_futureofyou_436116"},"futureofyou_435766":{"type":"posts","id":"futureofyou_435766","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435766","score":null,"sort":[1507134984000]},"guestAuthors":[],"slug":"spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says","title":"Spinal Patients Continue Remarkable Recovery After Stem Cell Injections, Company Says","publishDate":1507134984,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Patients with spinal injuries have continued to heal long after they’ve received an initial injection of stem cells, \u003ca href=\"http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3Chttp://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3E\">according to data\u003c/a> released Oct. 2 by the biotech company conducting a clinical trial on the treatment.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The rate of recovery at 12 months is more than double the rates of recovery seen at 12 months in both matched historical controls (29%) and published data in a similar patient population (26%).'\u003ccite>Asterias Biotherapeutics\u003c/cite>\u003c/aside>\n\u003cp>One year after six patients with severe spinal injuries were dosed with 10 million stem cells, four in the group have recovered at least two full motor levels of movement on at least one side of their bodies. That degree of improvement, based on the International Standards for Neurological Classification of Spinal Cord Injury \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/\" target=\"_blank\" rel=\"noopener\">scale\u003c/a>, is about twice the rate of recovery patients historically see, according to the company, Asterias Biotherapeutics of Fremont, California.\u003c/p>\n\u003cp>\"The rate of recovery at 12 months is more than double the rates of recovery seen at 12 months in both matched historical controls (29%) and published data in a similar patient population (26%),\" the company wrote in a press release.\u003c/p>\n\u003cp>According to Edward Wirth III, chief medical officer at Asterias, all six patients in the second cohort of the study progressed at least one motor level on one side; three patients improved two levels on one side; and one patient advanced three motor levels on one side. In addition, Wirth said, almost all the patients showed improvement on both sides of their bodies, and two of them jumped two motor levels on both sides.\u003c/p>\n\u003cp>Regaining two motor levels in spinocervical patients is significant. That could make the difference between full paralysis from the neck down, a condition that would require a ventilator to breathe, versus regaining some arm, hand and finger movement, allowing patients to take care of many of life’s daily tasks unassisted.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>We reported \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/23/stem-cells-may-have-restored-use-of-hands-and-arms-in-paralyzed-man/\">last year\u003c/a> on the striking initial results of this experimental phase 2 clinical trial, called \u003ca href=\"http://www.scistar-study.com/\">SCiStar.\u003c/a> The updated information suggests patients in this second cohort of the study not only received strong early benefit from the large single dose of stem cells, but that they have continued to improve over time.\u003c/p>\n\u003cp>Dr. Charles Liu, an investigator on the study and director of the USC Neurorestoration Center, has a patient in the second cohort of the trial, 21-year-old Kris Boesen of Fresno, whose substantial progress we first \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/03/23/strong-stem-cell-therapy-results-for-paralyzed-patients-company-says/\">reported\u003c/a> in September 2016.\u003c/p>\n\u003cp>Liu says most spinal-injury patients, once they’ve gone through initial recovery, tend to remain at the same level of movement.\u003c/p>\n\u003cp>“They can get a little bit better, but there’s definitely a point of plateau,\" Liu says.\u003c/p>\n\u003cp>But the new data from the trial shows continued progress. At the \u003ca href=\"http://www.globenewswire.com/NewsRoom/AttachmentNg/5f3b3123-31c5-48ec-be59-dd0b842a21ca\">six-month mark\u003c/a>, for instance, only two of the patients attained two-motor-level-improvement. After 12 months, two more had attained the milestone.\u003c/p>\n\u003cp>“Usually what you see is a plateau and that’s not what we’re seeing here. They continued to improve,” Liu says. “It was a durable effect. And that’s incredibly exciting.”\u003c/p>\n\u003cp>The six people in the second cohort obviously represent a small sample size, and some patients do spontaneously recover from spinal injuries. But Liu believes now that the replication of Boesen's progress has occurred in multiple patients, it’s more difficult to write them off as outliers.\u003c/p>\n\u003cp>There are five cohorts of patients in the study. The first received 2 million stem cells, the second 10 million, and the third is still in the process of receiving 20 million. The patients who received 2 million stem cells showed some benefit from the treatment, but not nearly as much as the 10-million-cell cohort.\u003cb> \u003c/b>The fourth and fifth cohorts target a different level of spinal injury, using dosages of 10 million and 20 million cells.\u003c/p>\n\u003cp>Enrollment is completed for the first four rounds of the trial; the fifth cohort's enrollment has begun and is expected to be completed by the end of this year, Asterias officials said.\u003c/p>\n\u003cp>The San Francisco Chronicle also \u003ca href=\"http://www.sfgate.com/health/article/Super-exciting-results-in-stem-cell-therapy-12245199.php\" target=\"_blank\" rel=\"noopener\">wrote about the trial\u003c/a> this week, in a front-page article. Reporter Erin Allday spoke with Christopher Block, a 31-year-old patient in the SCiStar trial who had virtually no movement in his arms after he injured his spinal cord in a biking accident.\u003c/p>\n\u003cp>“About a month after my stem cells, I was able to begin feeding myself,” Block told the Chronicle. He can now raise himself out of his wheelchair and change his shirt, he said.\u003c/p>\n\u003cp>On Monday, Asterias announced that the FDA had granted its request for designation of its stem cell treatment as a regenerative medicine advanced therapy, or \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm\" target=\"_blank\" rel=\"noopener\">RMAT\u003c/a>. One of the conditions of that designation is that preliminary clinical evidence indicates the treatment has \"potential to address unmet medical needs\" related to a \"serious or life-threatening disease or condition.\" The designation, which was created under the 21st Century Cures Act last year, was designed to accelerate review and approval by the FDA.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>SCiStar is partially funded by the California Institute for Regenerative Medicine, or CIRM, the publicly funded stem cell agency created by a state initiative in 2004.\u003c/p>\n\n","blocks":[],"excerpt":"Patients with spinal injuries have continued to heal long after they’ve received an initial injection of stem cells, according to data released by the biotech company conducting a clinical trial on the treatment.","status":"publish","parent":0,"modified":1508868436,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":20,"wordCount":888},"headData":{"title":"Spinal Patients Continue Remarkable Recovery After Stem Cell Injections, Company Says | KQED","description":"Patients with spinal injuries have continued to heal long after they’ve received an initial injection of stem cells, according to data released by the biotech company conducting a clinical trial on the treatment.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Spinal Patients Continue Remarkable Recovery After Stem Cell Injections, Company Says","datePublished":"2017-10-04T16:36:24.000Z","dateModified":"2017-10-24T18:07:16.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435766 https://ww2.kqed.org/futureofyou/?p=435766","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/10/04/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says/","disqusTitle":"Spinal Patients Continue Remarkable Recovery After Stem Cell Injections, Company Says","source":"Future of You","nprByline":"David Gorn\u003cbr />Future of You","path":"/futureofyou/435766/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Patients with spinal injuries have continued to heal long after they’ve received an initial injection of stem cells, \u003ca href=\"http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3Chttp://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3E\">according to data\u003c/a> released Oct. 2 by the biotech company conducting a clinical trial on the treatment.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The rate of recovery at 12 months is more than double the rates of recovery seen at 12 months in both matched historical controls (29%) and published data in a similar patient population (26%).'\u003ccite>Asterias Biotherapeutics\u003c/cite>\u003c/aside>\n\u003cp>One year after six patients with severe spinal injuries were dosed with 10 million stem cells, four in the group have recovered at least two full motor levels of movement on at least one side of their bodies. That degree of improvement, based on the International Standards for Neurological Classification of Spinal Cord Injury \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/\" target=\"_blank\" rel=\"noopener\">scale\u003c/a>, is about twice the rate of recovery patients historically see, according to the company, Asterias Biotherapeutics of Fremont, California.\u003c/p>\n\u003cp>\"The rate of recovery at 12 months is more than double the rates of recovery seen at 12 months in both matched historical controls (29%) and published data in a similar patient population (26%),\" the company wrote in a press release.\u003c/p>\n\u003cp>According to Edward Wirth III, chief medical officer at Asterias, all six patients in the second cohort of the study progressed at least one motor level on one side; three patients improved two levels on one side; and one patient advanced three motor levels on one side. In addition, Wirth said, almost all the patients showed improvement on both sides of their bodies, and two of them jumped two motor levels on both sides.\u003c/p>\n\u003cp>Regaining two motor levels in spinocervical patients is significant. That could make the difference between full paralysis from the neck down, a condition that would require a ventilator to breathe, versus regaining some arm, hand and finger movement, allowing patients to take care of many of life’s daily tasks unassisted.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>We reported \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/23/stem-cells-may-have-restored-use-of-hands-and-arms-in-paralyzed-man/\">last year\u003c/a> on the striking initial results of this experimental phase 2 clinical trial, called \u003ca href=\"http://www.scistar-study.com/\">SCiStar.\u003c/a> The updated information suggests patients in this second cohort of the study not only received strong early benefit from the large single dose of stem cells, but that they have continued to improve over time.\u003c/p>\n\u003cp>Dr. Charles Liu, an investigator on the study and director of the USC Neurorestoration Center, has a patient in the second cohort of the trial, 21-year-old Kris Boesen of Fresno, whose substantial progress we first \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/03/23/strong-stem-cell-therapy-results-for-paralyzed-patients-company-says/\">reported\u003c/a> in September 2016.\u003c/p>\n\u003cp>Liu says most spinal-injury patients, once they’ve gone through initial recovery, tend to remain at the same level of movement.\u003c/p>\n\u003cp>“They can get a little bit better, but there’s definitely a point of plateau,\" Liu says.\u003c/p>\n\u003cp>But the new data from the trial shows continued progress. At the \u003ca href=\"http://www.globenewswire.com/NewsRoom/AttachmentNg/5f3b3123-31c5-48ec-be59-dd0b842a21ca\">six-month mark\u003c/a>, for instance, only two of the patients attained two-motor-level-improvement. After 12 months, two more had attained the milestone.\u003c/p>\n\u003cp>“Usually what you see is a plateau and that’s not what we’re seeing here. They continued to improve,” Liu says. “It was a durable effect. And that’s incredibly exciting.”\u003c/p>\n\u003cp>The six people in the second cohort obviously represent a small sample size, and some patients do spontaneously recover from spinal injuries. But Liu believes now that the replication of Boesen's progress has occurred in multiple patients, it’s more difficult to write them off as outliers.\u003c/p>\n\u003cp>There are five cohorts of patients in the study. The first received 2 million stem cells, the second 10 million, and the third is still in the process of receiving 20 million. The patients who received 2 million stem cells showed some benefit from the treatment, but not nearly as much as the 10-million-cell cohort.\u003cb> \u003c/b>The fourth and fifth cohorts target a different level of spinal injury, using dosages of 10 million and 20 million cells.\u003c/p>\n\u003cp>Enrollment is completed for the first four rounds of the trial; the fifth cohort's enrollment has begun and is expected to be completed by the end of this year, Asterias officials said.\u003c/p>\n\u003cp>The San Francisco Chronicle also \u003ca href=\"http://www.sfgate.com/health/article/Super-exciting-results-in-stem-cell-therapy-12245199.php\" target=\"_blank\" rel=\"noopener\">wrote about the trial\u003c/a> this week, in a front-page article. Reporter Erin Allday spoke with Christopher Block, a 31-year-old patient in the SCiStar trial who had virtually no movement in his arms after he injured his spinal cord in a biking accident.\u003c/p>\n\u003cp>“About a month after my stem cells, I was able to begin feeding myself,” Block told the Chronicle. He can now raise himself out of his wheelchair and change his shirt, he said.\u003c/p>\n\u003cp>On Monday, Asterias announced that the FDA had granted its request for designation of its stem cell treatment as a regenerative medicine advanced therapy, or \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm\" target=\"_blank\" rel=\"noopener\">RMAT\u003c/a>. One of the conditions of that designation is that preliminary clinical evidence indicates the treatment has \"potential to address unmet medical needs\" related to a \"serious or life-threatening disease or condition.\" The designation, which was created under the 21st Century Cures Act last year, was designed to accelerate review and approval by the FDA.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>SCiStar is partially funded by the California Institute for Regenerative Medicine, or CIRM, the publicly funded stem cell agency created by a state initiative in 2004.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435766/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says","authors":["byline_futureofyou_435766"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1367","futureofyou_961","futureofyou_1275","futureofyou_1010","futureofyou_680"],"featImg":"futureofyou_243385","label":"source_futureofyou_435766"},"futureofyou_435135":{"type":"posts","id":"futureofyou_435135","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435135","score":null,"sort":[1504594861000]},"guestAuthors":[],"slug":"injecting-stem-cells-into-the-brain-reverses-parkinsons-symptoms-in-monkeys","title":"Injecting Stem Cells Into the Brain Reverses Parkinson's Symptoms in Monkeys","publishDate":1504594861,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Injecting neurons created from stem cells into the brain may relieve \u003ca href=\"https://www.statnews.com/2017/04/10/parkinsons-disease-stem-cells/\">Parkinson’s\u003c/a> symptoms, according to a new study in monkeys.\u003c/p>\n\u003cp>\u003cstrong>Why it matters:\u003c/strong>\u003cbr>\nParkinson’s disease can happen when some of a person’s dopamine-producing brain cells die, so replacing those neurons could be an effective treatment. Administering dopamine is part of currently accepted treatment, but over time the treatment has less effect as neurons die off and the side effects become difficult to manage. So scientists have begun studying approaches using stem cells, primarily in rodents. A clinical trial is also underway at the Royal Melbourne Hospital to inject neural stem cells into the brains of people with Parkinson’s as part of a Phase I clinical trial. Results are expected in 2019, and \u003ca href=\"http://www.neurology.org/content/88/16_Supplement/S4.004\" target=\"_blank\" rel=\"noopener noreferrer\">preliminary results\u003c/a> were presented at the American Academy of Neurology meeting this year.\u003c/p>\n\u003cp>\u003cstrong>The nitty-gritty:\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">A promising, but limited, study explores the effectiveness of reprogramming cells to treat Parkinson’s disease in monkeys.\u003c/aside>\n\u003cp>Researchers collected skin or blood cells from seven humans, some who had Parkinson’s disease and some who did not. (The people with Parkinson’s did not have any of the genes thought to be associated with the disease.) Next, using sets of proteins, they “reprogrammed” some of those cells and encouraged them to grow up as neurons — specifically, neurons that could produce dopamine. Finally, they injected the stem cells into the brains of monkeys that were treated with a neurotoxin, which made them act like they had the condition.\u003c/p>\n\u003cp>Researchers found that the symptoms of the monkeys treated with stem cells from either group improved more over the course of a year than monkeys treated with a placebo injection. To determine if the monkey’s symptoms had improved, the team evaluated their tremors, movements, and posture, among other things. The team published its results in \u003cem>Nature\u003c/em> on Wednesday.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“I think that a stem cell-based therapy will bring more benefits than conventional treatments can do now,” said Dr. Jun Takahashi, a professor at Kyoto University and one of the authors of the paper.\u003c/p>\n\u003cp>[contextly_sidebar id=\"ex7AnVDkQO8jZL68Sjrm8akZZfHqgkNW\"]\u003cstrong>You should know:\u003c/strong>\u003cbr>\nAmong conventional treatments for Parkinson’s is a medication called L-DOPA, which ultimately helps patients replace some of the dopamine they can no longer produce. Another accepted procedure is deep brain stimulation, which sparked Takahashi’s interest in this project, he said.\u003c/p>\n\u003cp>Takahashi and his team did not run tests comparing their results to those seen after deep-brain stimulation and L-DOPA treatment, but they did compare their findings to published statistics. They concluded that the transplants “should exert [similar] effects.”\u003c/p>\n\u003cp>\u003cstrong>What they’re saying:\u003c/strong>\u003cbr>\nDr. Lorenz Studer, director of the center for stem cell biology at Memorial Sloan Kettering Cancer Center, said Takahashi’s work was “a very impressive study,” especially given the number of animals, the length of time they were followed, and the similarity of the protocols used to those that might be used in human trials. “In this regard, it was a really interesting test run,” he said.\u003c/p>\n\u003cp>“It is probably the best study to date using the induced pluripotent stem cells,” said Studer, who was not involved in the research.\u003c/p>\n\u003cp>\u003cstrong>But keep in mind:\u003c/strong>\u003cbr>\nThe study isn’t without limitations. Studer noted that the volume of neurons that survived varied widely between monkeys, with no clear behavioral impact. Additional, he said that this paper didn’t particularly characterize cells that were not dopamine-producing. “Whatever they are, they didn’t really cause any problems,” he said. “In the clinic, that’s kind of important to know.”\u003c/p>\n\u003cp>And more research should also be done to figure out how to identify cell lines that would work best in this kind of treatment, the paper noted.\u003c/p>\n\u003cp>Takahashi said he plans to start clinical trials in 2018.\u003c/p>\n\u003cp>\u003cstrong>The bottom line:\u003c/strong>\u003cbr>\nThis study adds more convincing animal evidence of the promise of stem cells in treating Parkinson’s disease, and human trials may soon give an even clearer picture.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/30/neural-stem-cells-parkinsons/\" target=\"_blank\" rel=\"noopener noreferrer\">story \u003c/a>was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\n","blocks":[],"excerpt":"Parkinson's disease can happen when some of a person's dopamine-producing brain cells die, so replacing those neurons could be an effective treatment.","status":"publish","parent":0,"modified":1504729673,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":17,"wordCount":726},"headData":{"title":"Injecting Stem Cells Into the Brain Reverses Parkinson's Symptoms in Monkeys | KQED","description":"Parkinson's disease can happen when some of a person's dopamine-producing brain cells die, so replacing those neurons could be an effective treatment.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Injecting Stem Cells Into the Brain Reverses Parkinson's Symptoms in Monkeys","datePublished":"2017-09-05T07:01:01.000Z","dateModified":"2017-09-06T20:27:53.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435135 https://ww2.kqed.org/futureofyou/?p=435135","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/09/05/injecting-stem-cells-into-the-brain-reverses-parkinsons-symptoms-in-monkeys/","disqusTitle":"Injecting Stem Cells Into the Brain Reverses Parkinson's Symptoms in Monkeys","nprByline":"Kate Sheridan\u003c/br>\u003ca href=\"https://www.statnews.com/2017/08/30/neural-stem-cells-parkinsons/\">STAT\u003c/a>","path":"/futureofyou/435135/injecting-stem-cells-into-the-brain-reverses-parkinsons-symptoms-in-monkeys","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Injecting neurons created from stem cells into the brain may relieve \u003ca href=\"https://www.statnews.com/2017/04/10/parkinsons-disease-stem-cells/\">Parkinson’s\u003c/a> symptoms, according to a new study in monkeys.\u003c/p>\n\u003cp>\u003cstrong>Why it matters:\u003c/strong>\u003cbr>\nParkinson’s disease can happen when some of a person’s dopamine-producing brain cells die, so replacing those neurons could be an effective treatment. Administering dopamine is part of currently accepted treatment, but over time the treatment has less effect as neurons die off and the side effects become difficult to manage. So scientists have begun studying approaches using stem cells, primarily in rodents. A clinical trial is also underway at the Royal Melbourne Hospital to inject neural stem cells into the brains of people with Parkinson’s as part of a Phase I clinical trial. Results are expected in 2019, and \u003ca href=\"http://www.neurology.org/content/88/16_Supplement/S4.004\" target=\"_blank\" rel=\"noopener noreferrer\">preliminary results\u003c/a> were presented at the American Academy of Neurology meeting this year.\u003c/p>\n\u003cp>\u003cstrong>The nitty-gritty:\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">A promising, but limited, study explores the effectiveness of reprogramming cells to treat Parkinson’s disease in monkeys.\u003c/aside>\n\u003cp>Researchers collected skin or blood cells from seven humans, some who had Parkinson’s disease and some who did not. (The people with Parkinson’s did not have any of the genes thought to be associated with the disease.) Next, using sets of proteins, they “reprogrammed” some of those cells and encouraged them to grow up as neurons — specifically, neurons that could produce dopamine. Finally, they injected the stem cells into the brains of monkeys that were treated with a neurotoxin, which made them act like they had the condition.\u003c/p>\n\u003cp>Researchers found that the symptoms of the monkeys treated with stem cells from either group improved more over the course of a year than monkeys treated with a placebo injection. To determine if the monkey’s symptoms had improved, the team evaluated their tremors, movements, and posture, among other things. The team published its results in \u003cem>Nature\u003c/em> on Wednesday.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“I think that a stem cell-based therapy will bring more benefits than conventional treatments can do now,” said Dr. Jun Takahashi, a professor at Kyoto University and one of the authors of the paper.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>\u003cstrong>You should know:\u003c/strong>\u003cbr>\nAmong conventional treatments for Parkinson’s is a medication called L-DOPA, which ultimately helps patients replace some of the dopamine they can no longer produce. Another accepted procedure is deep brain stimulation, which sparked Takahashi’s interest in this project, he said.\u003c/p>\n\u003cp>Takahashi and his team did not run tests comparing their results to those seen after deep-brain stimulation and L-DOPA treatment, but they did compare their findings to published statistics. They concluded that the transplants “should exert [similar] effects.”\u003c/p>\n\u003cp>\u003cstrong>What they’re saying:\u003c/strong>\u003cbr>\nDr. Lorenz Studer, director of the center for stem cell biology at Memorial Sloan Kettering Cancer Center, said Takahashi’s work was “a very impressive study,” especially given the number of animals, the length of time they were followed, and the similarity of the protocols used to those that might be used in human trials. “In this regard, it was a really interesting test run,” he said.\u003c/p>\n\u003cp>“It is probably the best study to date using the induced pluripotent stem cells,” said Studer, who was not involved in the research.\u003c/p>\n\u003cp>\u003cstrong>But keep in mind:\u003c/strong>\u003cbr>\nThe study isn’t without limitations. Studer noted that the volume of neurons that survived varied widely between monkeys, with no clear behavioral impact. Additional, he said that this paper didn’t particularly characterize cells that were not dopamine-producing. “Whatever they are, they didn’t really cause any problems,” he said. “In the clinic, that’s kind of important to know.”\u003c/p>\n\u003cp>And more research should also be done to figure out how to identify cell lines that would work best in this kind of treatment, the paper noted.\u003c/p>\n\u003cp>Takahashi said he plans to start clinical trials in 2018.\u003c/p>\n\u003cp>\u003cstrong>The bottom line:\u003c/strong>\u003cbr>\nThis study adds more convincing animal evidence of the promise of stem cells in treating Parkinson’s disease, and human trials may soon give an even clearer picture.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/30/neural-stem-cells-parkinsons/\" target=\"_blank\" rel=\"noopener noreferrer\">story \u003c/a>was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435135/injecting-stem-cells-into-the-brain-reverses-parkinsons-symptoms-in-monkeys","authors":["byline_futureofyou_435135"],"categories":["futureofyou_1062"],"tags":["futureofyou_1242","futureofyou_680"],"featImg":"futureofyou_435136","label":"futureofyou"},"futureofyou_435066":{"type":"posts","id":"futureofyou_435066","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435066","score":null,"sort":[1503945965000]},"guestAuthors":[],"slug":"feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics","title":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics","publishDate":1503945965,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.\u003c/p>\n\u003cp class=\"danger-zone\">The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm\" target=\"_blank\" rel=\"noopener noreferrer\">announced\u003c/a> Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'\u003ccite> FDA Commissioner Scott Gottlieb\u003c/cite>\u003c/aside>\n\u003cp>The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.\u003c/p>\n\u003cp>The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.\u003c/p>\n\u003cp>“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” FDA Commissioner Scott Gottlieb said in a statement. “I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>A complaint filed in federal court indicates the vials were shipped from outside California but does not provide more detail on the origin. StemImmune also filed \u003ca href=\"http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2&p=1&f=G&l=50&d=PG01&S1=Stemimmune.AANM.&OS=AANM/Stemimmune&RS=AANM/Stemimmune\" target=\"_blank\" rel=\"noopener noreferrer\">a patent application\u003c/a> in February describing “the use of smallpox vaccine to induce an effective anti-tumor immune response.”\u003c/p>\n\u003cp>The type of vaccine that was seized \u003ca href=\"https://www.cdc.gov/smallpox/vaccine-basics/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">is made \u003c/a>from a virus similar to smallpox, but it does not contain smallpox virus and cannot give anyone smallpox, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Also Monday, the FDA announced it had sent \u003ca href=\"https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a warning letter\u003c/a> to a Florida stem cell clinic where a 2015 procedure led three women to go legally blind, according \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">to a March study\u003c/a> in the New England Journal of Medicine. The letter to U.S. Stem Cell Clinic said that the company was offering unapproved stem cell treatments and that an agency inspection uncovered violations of manufacturing standards, including potential sterility issues. The company also tried to stop FDA inspectors from talking with employees, the letter says.\u003c/p>\n\u003cp>“You should take prompt action to correct these deviations,” says the letter, which was sent Thursday. “Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.”\u003c/p>\n\u003cp>StemImmune did not respond immediately to a request for comment. In a statement, U.S. Stem Cell Clinic said it had given the FDA “unrestricted access” since 2014 and that it followed the agency’s rules. But it also suggested that regulations could prevent patients from getting treatments.\u003c/p>\n\u003cp>“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the [FDA],” it said, adding: “We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”\u003c/p>\n\u003cp>The actions announced Monday are the latest salvo in a back-and-forth between regulators and the clinics that claim to be able to treat everything from paralysis to neurodegenerative diseases to erectile dysfunction. The clinics, \u003ca href=\"https://www.statnews.com/2016/06/30/stem-cell-clinics-proliferate/\">which have proliferated\u003c/a> around the country in recent years, have largely evaded regulation enforcement because they typically take a person’s own stem cells and inject them back into the same person, meaning the cells are considered “minimally manipulated.”\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/\">FDA has tried\u003c/a> at various times to regulate clinics offering unproven stem cell treatments more tightly and close down clinics that put patients at risk, but overall, their efforts have not amounted to much.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/09/09/stem-cell-fda-hearing/\">FDA has held meetings\u003c/a> about possibly regulating the therapies more like drugs, a move that has been backed by many academic stem cell experts who say that stem cell therapies, while holding great potential, are not ready to be used widely or outside regulated clinical trials. But clinic owners warn that the FDA could stamp out progress in the field and keep desperate patients from getting treatments.\u003c/p>\n\u003cp>“The government should not regulate our bodies. … I will always stand up for patient rights,” Kristin Comella, U.S. Stem Cell’s chief scientific officer, said at an FDA hearing months ago. (The FDA’s warning letter this month was addressed to Comella.)\u003c/p>\n\u003cp>Some experts have wondered whether the regulation-averse Trump administration would take further action against stem cell clinics. But in a statement Monday, Gottlieb said the FDA would be bolstering its enforcement as a way of “separating the promise from the unscrupulous hype” and that the agency would roll out a new “comprehensive policy framework” this fall to delineate the rules for stem cell treatments.\u003c/p>\n\u003cp>“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said. “These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This put the entire field at risk.”\u003c/p>\n\u003cp>Experts who study stem cell clinics and the regulatory landscape generally praised the FDA’s moves, but said that it was unclear what the enforcement actions and \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Gottlieb’s statement\u003c/a> meant for the field going forward.\u003c/p>\n\u003cp>“The most important thing is that the FDA is now publicly making a commitment to discipline what has become an out-of-control area of fraudulent medicine,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.\u003c/p>\n\u003cp>One part of Gottlieb’s statement that stuck out to Charo, she said, was when he signaled some flexibility in terms of the areas that are subject to FDA regulation, with the commissioner writing that “the FDA must advance an efficient and least burdensome framework” and establish “a regulatory structure that does not become a barrier to beneficial new innovation.”\u003c/p>\n\u003cp>“It’s about a tone being set,” Charo said.\u003c/p>\n\u003cp>Leigh Turner, a University of Minnesota bioethicist, said that from one standpoint, the FDA’s enforcement actions targeted the low-hanging fruit of the bad actors in the industry. Presumably any administration would want to seize unauthorized smallpox vaccine supplies, and the Florida clinic was the subject of lawsuits and media coverage in addition to the high-profile academic paper.\u003c/p>\n\u003cp>“The larger question is going to be, what about the stem cell clinics … that are out there marketing therapies and charging people but don’t have a New England Journal of Medicine piece or lawsuits?” Turner asked. “Is it just going to be that after harm occurs that the FDA is going to do something? Or are we going to see a more systemic approach to this marketplace?”\u003c/p>\n\u003cp>The action against the California clinics was solely based on the vaccine, noted Turner, who \u003ca href=\"http://www.cell.com/cell-stem-cell/abstract/S1934-5909(16)30157-6\" target=\"_blank\" rel=\"noopener noreferrer\">has tracked\u003c/a> the growth of clinics around the country. It did not mention all the other diseases and conditions that the clinics have been marketing their unapproved stem cell therapies for.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/28/smallpox-stem-cell-clinic/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations.","status":"publish","parent":0,"modified":1504028625,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":26,"wordCount":1398},"headData":{"title":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics | KQED","description":"Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics","datePublished":"2017-08-28T18:46:05.000Z","dateModified":"2017-08-29T17:43:45.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435066 https://ww2.kqed.org/futureofyou/?p=435066","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/08/28/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics/","disqusTitle":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics","source":"STAT","nprByline":"Andrew Joseph \u003cbr/>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/435066/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.\u003c/p>\n\u003cp class=\"danger-zone\">The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm\" target=\"_blank\" rel=\"noopener noreferrer\">announced\u003c/a> Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'\u003ccite> FDA Commissioner Scott Gottlieb\u003c/cite>\u003c/aside>\n\u003cp>The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.\u003c/p>\n\u003cp>The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.\u003c/p>\n\u003cp>“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” FDA Commissioner Scott Gottlieb said in a statement. “I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>A complaint filed in federal court indicates the vials were shipped from outside California but does not provide more detail on the origin. StemImmune also filed \u003ca href=\"http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2&p=1&f=G&l=50&d=PG01&S1=Stemimmune.AANM.&OS=AANM/Stemimmune&RS=AANM/Stemimmune\" target=\"_blank\" rel=\"noopener noreferrer\">a patent application\u003c/a> in February describing “the use of smallpox vaccine to induce an effective anti-tumor immune response.”\u003c/p>\n\u003cp>The type of vaccine that was seized \u003ca href=\"https://www.cdc.gov/smallpox/vaccine-basics/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">is made \u003c/a>from a virus similar to smallpox, but it does not contain smallpox virus and cannot give anyone smallpox, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Also Monday, the FDA announced it had sent \u003ca href=\"https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a warning letter\u003c/a> to a Florida stem cell clinic where a 2015 procedure led three women to go legally blind, according \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">to a March study\u003c/a> in the New England Journal of Medicine. The letter to U.S. Stem Cell Clinic said that the company was offering unapproved stem cell treatments and that an agency inspection uncovered violations of manufacturing standards, including potential sterility issues. The company also tried to stop FDA inspectors from talking with employees, the letter says.\u003c/p>\n\u003cp>“You should take prompt action to correct these deviations,” says the letter, which was sent Thursday. “Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.”\u003c/p>\n\u003cp>StemImmune did not respond immediately to a request for comment. In a statement, U.S. Stem Cell Clinic said it had given the FDA “unrestricted access” since 2014 and that it followed the agency’s rules. But it also suggested that regulations could prevent patients from getting treatments.\u003c/p>\n\u003cp>“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the [FDA],” it said, adding: “We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”\u003c/p>\n\u003cp>The actions announced Monday are the latest salvo in a back-and-forth between regulators and the clinics that claim to be able to treat everything from paralysis to neurodegenerative diseases to erectile dysfunction. The clinics, \u003ca href=\"https://www.statnews.com/2016/06/30/stem-cell-clinics-proliferate/\">which have proliferated\u003c/a> around the country in recent years, have largely evaded regulation enforcement because they typically take a person’s own stem cells and inject them back into the same person, meaning the cells are considered “minimally manipulated.”\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/\">FDA has tried\u003c/a> at various times to regulate clinics offering unproven stem cell treatments more tightly and close down clinics that put patients at risk, but overall, their efforts have not amounted to much.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/09/09/stem-cell-fda-hearing/\">FDA has held meetings\u003c/a> about possibly regulating the therapies more like drugs, a move that has been backed by many academic stem cell experts who say that stem cell therapies, while holding great potential, are not ready to be used widely or outside regulated clinical trials. But clinic owners warn that the FDA could stamp out progress in the field and keep desperate patients from getting treatments.\u003c/p>\n\u003cp>“The government should not regulate our bodies. … I will always stand up for patient rights,” Kristin Comella, U.S. Stem Cell’s chief scientific officer, said at an FDA hearing months ago. (The FDA’s warning letter this month was addressed to Comella.)\u003c/p>\n\u003cp>Some experts have wondered whether the regulation-averse Trump administration would take further action against stem cell clinics. But in a statement Monday, Gottlieb said the FDA would be bolstering its enforcement as a way of “separating the promise from the unscrupulous hype” and that the agency would roll out a new “comprehensive policy framework” this fall to delineate the rules for stem cell treatments.\u003c/p>\n\u003cp>“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said. “These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This put the entire field at risk.”\u003c/p>\n\u003cp>Experts who study stem cell clinics and the regulatory landscape generally praised the FDA’s moves, but said that it was unclear what the enforcement actions and \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Gottlieb’s statement\u003c/a> meant for the field going forward.\u003c/p>\n\u003cp>“The most important thing is that the FDA is now publicly making a commitment to discipline what has become an out-of-control area of fraudulent medicine,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.\u003c/p>\n\u003cp>One part of Gottlieb’s statement that stuck out to Charo, she said, was when he signaled some flexibility in terms of the areas that are subject to FDA regulation, with the commissioner writing that “the FDA must advance an efficient and least burdensome framework” and establish “a regulatory structure that does not become a barrier to beneficial new innovation.”\u003c/p>\n\u003cp>“It’s about a tone being set,” Charo said.\u003c/p>\n\u003cp>Leigh Turner, a University of Minnesota bioethicist, said that from one standpoint, the FDA’s enforcement actions targeted the low-hanging fruit of the bad actors in the industry. Presumably any administration would want to seize unauthorized smallpox vaccine supplies, and the Florida clinic was the subject of lawsuits and media coverage in addition to the high-profile academic paper.\u003c/p>\n\u003cp>“The larger question is going to be, what about the stem cell clinics … that are out there marketing therapies and charging people but don’t have a New England Journal of Medicine piece or lawsuits?” Turner asked. “Is it just going to be that after harm occurs that the FDA is going to do something? Or are we going to see a more systemic approach to this marketplace?”\u003c/p>\n\u003cp>The action against the California clinics was solely based on the vaccine, noted Turner, who \u003ca href=\"http://www.cell.com/cell-stem-cell/abstract/S1934-5909(16)30157-6\" target=\"_blank\" rel=\"noopener noreferrer\">has tracked\u003c/a> the growth of clinics around the country. It did not mention all the other diseases and conditions that the clinics have been marketing their unapproved stem cell therapies for.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/28/smallpox-stem-cell-clinic/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435066/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics","authors":["byline_futureofyou_435066"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_38","futureofyou_1275","futureofyou_1345","futureofyou_680","futureofyou_1346"],"featImg":"futureofyou_435072","label":"source_futureofyou_435066"},"futureofyou_401647":{"type":"posts","id":"futureofyou_401647","meta":{"index":"posts_1591205157","site":"futureofyou","id":"401647","score":null,"sort":[1497297465000]},"guestAuthors":[],"slug":"company-want-to-bring-the-dead-back-to-life-no-really","title":"Company Wants to Bring the Dead Back to Life (No, Really)","publishDate":1497297465,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp class=\"danger-zone\">For any given medical problem, it seems, there’s a research team trying to use stem cells to find a solution. In clinical trials to treat everything from \u003ca href=\"https://www.statnews.com/2016/06/16/stem-cell-diabetes-treatment/\">diabetes\u003c/a> to \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">macular degeneration\u003c/a> to \u003ca href=\"https://www.statnews.com/2017/05/25/pipeline-als-treatments/\">ALS\u003c/a>, researchers are injecting the cells in efforts to cure patients.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It’s not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero.'\u003c/aside>\n\u003cp>The idea of the trial, run by Philadelphia-based Bioquark, is to inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.But in one study expected to launch later this year, scientists hope to use stem cells in a new, highly controversial way — to reverse death.\u003c/p>\n\u003cp class=\"danger-zone\">The idea of the trial, run by Philadelphia-based Bioquark, is to inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.\u003c/p>\n\u003cp class=\"danger-zone\">The ultimate goal: to grow new neurons and spur them to connect to each other, and thereby bring the brain back to life.\u003c/p>\n\u003cp class=\"danger-zone\">“It’s our contention that there’s no single magic bullet for this, so to start with a single magic bullet makes no sense. Hence why we have to take a different approach,” said Ira Pastor, CEO of Bioquark.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"danger-zone\">But the scientific literature — scarce as it is — seems to show that even several magic bullets are unlikely to accomplish what Bioquark hopes it will.\u003c/p>\n\u003cp>This isn’t the first start for the trial. The study launched in Rudrapur, India, in April 2016 — but it never enrolled any patients. Regulators shut the study down in November 2016 because, according to \u003ca href=\"http://www.sciencemag.org/news/2016/11/experiment-raise-dead-blocked-india\" target=\"_blank\" rel=\"noopener noreferrer\">Science\u003c/a>, India’s Drug Controller General hadn’t cleared it.\u003c/p>\n\u003cp>Now, Pastor said, the company is in the final stages of finding a new location to host trials. The company will announce a trial in Latin America in coming months, Pastor told STAT.\u003c/p>\n\u003cp>If that trial mirrors the protocol for the \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02742857\" target=\"_blank\" rel=\"noopener noreferrer\">halted Indian one\u003c/a>, it’ll aim to enroll 20 patients who’ll receive a barrage of treatments. First there’s the injection of stem cells isolated from the individual’s own fat or blood. Second, there’s a peptide formula injected into the spinal cord, purported to help nurture new neurons’ growth. (The company has tested the same concoction, called BQ-A, in animal models of melanoma, traumatic brain injuries, and skin wrinkling.) Third, there’s a regimen of nerve stimulation and laser therapy over 15 days to spur the neurons to form connections. Researchers will look to behavior and EEG for signs that the treatment is working.\u003c/p>\n\u003cp>But the process is fraught with questions. How do researchers complete trial paperwork when the person participating is, legally, dead? (In the United States, state laws most often define death as the irreversible loss of heart and lung or brain function.) If the person did regain brain activity, what kind of functional abilities would he or she have? Are families getting their hopes up for an incredibly long-shot cure?\u003c/p>\n\u003cp>Answers to most of those questions are still far off. “Of course, many folks are asking the ‘what comes next?’ question,” Pastor acknowledged. “While full recovery in such patients is indeed a long term vision of ours, and a possibility that we foresee with continued work along this path, it is not the core focus or primary endpoint of this first protocol.”\u003c/p>\n\u003ch2>\u003cstrong>Simply quirky or mostly quackery?\u003c/strong>\u003c/h2>\n\u003cp>No real template exists to know whether this approach might work — and it’s gotten some prominent backlash. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118884/\" target=\"_blank\" rel=\"noopener noreferrer\">wrote in a 2016\u003c/a> editorial that the trial “borders on quackery,” “has no scientific foundation,” and gave families “a cruel, false hope for recovery.” (“Exploratory research programs of this nature are not false hope. They are a glimmer of hope,” Pastor \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5303606/\" target=\"_blank\" rel=\"noopener noreferrer\">responded\u003c/a>.)\u003c/p>\n\u003cp>The company hasn’t tested the full, four-pronged treatment, even in animal models. Studies have evaluated the treatments singly for other conditions — stroke, coma — but brain death is a quite different proposition.\u003c/p>\n\u003cp>Stem cell injections to the brain or spinal cord have shown some positive results for \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01019733?term=stem+cell+brain&rank=4\" target=\"_blank\" rel=\"noopener noreferrer\">children with brain injuries\u003c/a>; trials using similar procedures to treat \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01978821?term=stem+cell+brain&rank=13\" target=\"_blank\" rel=\"noopener noreferrer\">cerebral\u003c/a> \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01763255?term=stem+cell+brain&rank=21\" target=\"_blank\" rel=\"noopener noreferrer\">palsy\u003c/a> and \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02383654?term=stem+cell+brain&rank=37\" target=\"_blank\" rel=\"noopener noreferrer\">ALS\u003c/a> have also been completed. One \u003ca href=\"http://www.reneuron.com/clinical-trials/phase-ii-clinical-trial-in-stroke-disability-pisces-ii/\" target=\"_blank\" rel=\"noopener noreferrer\">small, uncontrolled study\u003c/a> of 21 stroke patients found that they recovered more mobility after they received an injection of donor stem cells into their brains.\u003c/p>\n\u003cp>On transcranial laser devices, the evidence is mixed. The approach has been shown to stimulate neuron growth in some animal studies. However, a high-profile Phase 3 study of one such device in humans was \u003ca href=\"http://stroke.ahajournals.org/content/45/11/3187.long\" target=\"_blank\" rel=\"noopener noreferrer\">halted\u003c/a> in 2014 after it showed no effect on 600 patients’ physical capabilities as they recovered from a stroke. \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02645578?term=right+median+nerve+stimulation&rank=1\" target=\"_blank\" rel=\"noopener noreferrer\">Other\u003c/a> \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02645578\" target=\"_blank\" rel=\"noopener noreferrer\">trials\u003c/a> to revive people from comas using laser therapy are underway.\u003c/p>\n\u003cp>The literature around electrical stimulation of the median nerve — which branches from the spinal cord down the arm and to the fingers — primarily consists of case studies. Dr. Ed Cooper wrote some of those papers, one of which described dozens of patients treated in his home state of North Carolina, including 12 who had a Glasgow Coma Score of 4 — an extremely low score on the scale. With time (and with the nerve stimulation), four of those 12 people made a “good recovery,” the paper described; others were left with minor or major disabilities after their coma.\u003c/p>\n\u003cp>But Cooper, an orthopedic surgeon by training who worked with neurosurgeons on the paper, said unequivocally that there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem — one of the structures that most motor neurons go through before connecting with the cortex proper. If there’s no functional brain stem, then it can’t work.\u003c/p>\n\u003cp>Pastor agreed — but he claimed the technique would work because there are “a small nest of cells” that still function in patients who are brain-dead.\u003c/p>\n\u003cp>Complicating such trials, there is no clear-cut confirmatory test for brain death — meaning a recovery in the trial might not be entirely due to the treatment. Some poisons and drugs, for instance, can make people look brain-dead. Bioquark plans to rely on local physicians in the trial’s host country to make the declaration. “We’re not doing the confirmatory work ourselves,” Pastor said, but each participant would have undergone a battery of tests considered appropriate by local authorities.\u003c/p>\n\u003cp>But a \u003ca href=\"http://www.neurology.org/content/74/23/1911.full\" target=\"_blank\" rel=\"noopener noreferrer\">survey of 38 papers\u003c/a> published over 13 years found that, if the American Academy of Neurology guidelines for brain death had been met, no brain-dead people have ever regained brain function.\u003c/p>\n\u003cp>Of Bioquark’s full protocol, “it’s not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero,” said Dr. Charles Cox, a pediatric surgeon who \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT00254722?term=stem+cell+brain&rank=10\" target=\"_blank\" rel=\"noopener noreferrer\">has done research\u003c/a> with mesenchymal stem cells — the type used in the trial — at the University of Texas Health Science Center at Houston. Cox is not involved in Bioquark’s work.\u003c/p>\n\u003cp>Some studies have found that cells from a part of the brain called the subventricular zone can grow in culture even after a person is declared dead, Cox said. However, it’s unlikely that the trial’s intended outcome — to have a stem cell treatment result in new neurons or connections — would actually happen. Neurons would likely struggle to survive, because blood flow to the brain is almost always lost in people who have been declared brain-dead, Cox said.\u003c/p>\n\u003cp>But Pastor thinks Bioquark’s protocol will work. “I give us a pretty good chance,” he said. “I just think it’s a matter of putting it all together and getting the right people and the right minds on it.”\u003c/p>\n\u003cp>Cox is less optimistic. “I think [someone reviving] would technically be a miracle,” he said. “I think the pope would technically call that a miracle.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This story was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"But in one study expected to launch later this year, scientists hope to use stem cells in a new, highly controversial way — to reverse death.","status":"publish","parent":0,"modified":1497390822,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":22,"wordCount":1501},"headData":{"title":"Company Wants to Bring the Dead Back to Life (No, Really) | KQED","description":"But in one study expected to launch later this year, scientists hope to use stem cells in a new, highly controversial way — to reverse death.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Company Wants to Bring the Dead Back to Life (No, Really)","datePublished":"2017-06-12T19:57:45.000Z","dateModified":"2017-06-13T21:53:42.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"401647 https://ww2.kqed.org/futureofyou/?p=401647","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/06/12/company-want-to-bring-the-dead-back-to-life-no-really/","disqusTitle":"Company Wants to Bring the Dead Back to Life (No, Really)","nprByline":"Kate Sheridan\u003cBR />\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/401647/company-want-to-bring-the-dead-back-to-life-no-really","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">For any given medical problem, it seems, there’s a research team trying to use stem cells to find a solution. In clinical trials to treat everything from \u003ca href=\"https://www.statnews.com/2016/06/16/stem-cell-diabetes-treatment/\">diabetes\u003c/a> to \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">macular degeneration\u003c/a> to \u003ca href=\"https://www.statnews.com/2017/05/25/pipeline-als-treatments/\">ALS\u003c/a>, researchers are injecting the cells in efforts to cure patients.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It’s not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero.'\u003c/aside>\n\u003cp>The idea of the trial, run by Philadelphia-based Bioquark, is to inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.But in one study expected to launch later this year, scientists hope to use stem cells in a new, highly controversial way — to reverse death.\u003c/p>\n\u003cp class=\"danger-zone\">The idea of the trial, run by Philadelphia-based Bioquark, is to inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.\u003c/p>\n\u003cp class=\"danger-zone\">The ultimate goal: to grow new neurons and spur them to connect to each other, and thereby bring the brain back to life.\u003c/p>\n\u003cp class=\"danger-zone\">“It’s our contention that there’s no single magic bullet for this, so to start with a single magic bullet makes no sense. Hence why we have to take a different approach,” said Ira Pastor, CEO of Bioquark.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">But the scientific literature — scarce as it is — seems to show that even several magic bullets are unlikely to accomplish what Bioquark hopes it will.\u003c/p>\n\u003cp>This isn’t the first start for the trial. The study launched in Rudrapur, India, in April 2016 — but it never enrolled any patients. Regulators shut the study down in November 2016 because, according to \u003ca href=\"http://www.sciencemag.org/news/2016/11/experiment-raise-dead-blocked-india\" target=\"_blank\" rel=\"noopener noreferrer\">Science\u003c/a>, India’s Drug Controller General hadn’t cleared it.\u003c/p>\n\u003cp>Now, Pastor said, the company is in the final stages of finding a new location to host trials. The company will announce a trial in Latin America in coming months, Pastor told STAT.\u003c/p>\n\u003cp>If that trial mirrors the protocol for the \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02742857\" target=\"_blank\" rel=\"noopener noreferrer\">halted Indian one\u003c/a>, it’ll aim to enroll 20 patients who’ll receive a barrage of treatments. First there’s the injection of stem cells isolated from the individual’s own fat or blood. Second, there’s a peptide formula injected into the spinal cord, purported to help nurture new neurons’ growth. (The company has tested the same concoction, called BQ-A, in animal models of melanoma, traumatic brain injuries, and skin wrinkling.) Third, there’s a regimen of nerve stimulation and laser therapy over 15 days to spur the neurons to form connections. Researchers will look to behavior and EEG for signs that the treatment is working.\u003c/p>\n\u003cp>But the process is fraught with questions. How do researchers complete trial paperwork when the person participating is, legally, dead? (In the United States, state laws most often define death as the irreversible loss of heart and lung or brain function.) If the person did regain brain activity, what kind of functional abilities would he or she have? Are families getting their hopes up for an incredibly long-shot cure?\u003c/p>\n\u003cp>Answers to most of those questions are still far off. “Of course, many folks are asking the ‘what comes next?’ question,” Pastor acknowledged. “While full recovery in such patients is indeed a long term vision of ours, and a possibility that we foresee with continued work along this path, it is not the core focus or primary endpoint of this first protocol.”\u003c/p>\n\u003ch2>\u003cstrong>Simply quirky or mostly quackery?\u003c/strong>\u003c/h2>\n\u003cp>No real template exists to know whether this approach might work — and it’s gotten some prominent backlash. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118884/\" target=\"_blank\" rel=\"noopener noreferrer\">wrote in a 2016\u003c/a> editorial that the trial “borders on quackery,” “has no scientific foundation,” and gave families “a cruel, false hope for recovery.” (“Exploratory research programs of this nature are not false hope. They are a glimmer of hope,” Pastor \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5303606/\" target=\"_blank\" rel=\"noopener noreferrer\">responded\u003c/a>.)\u003c/p>\n\u003cp>The company hasn’t tested the full, four-pronged treatment, even in animal models. Studies have evaluated the treatments singly for other conditions — stroke, coma — but brain death is a quite different proposition.\u003c/p>\n\u003cp>Stem cell injections to the brain or spinal cord have shown some positive results for \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01019733?term=stem+cell+brain&rank=4\" target=\"_blank\" rel=\"noopener noreferrer\">children with brain injuries\u003c/a>; trials using similar procedures to treat \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01978821?term=stem+cell+brain&rank=13\" target=\"_blank\" rel=\"noopener noreferrer\">cerebral\u003c/a> \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01763255?term=stem+cell+brain&rank=21\" target=\"_blank\" rel=\"noopener noreferrer\">palsy\u003c/a> and \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02383654?term=stem+cell+brain&rank=37\" target=\"_blank\" rel=\"noopener noreferrer\">ALS\u003c/a> have also been completed. One \u003ca href=\"http://www.reneuron.com/clinical-trials/phase-ii-clinical-trial-in-stroke-disability-pisces-ii/\" target=\"_blank\" rel=\"noopener noreferrer\">small, uncontrolled study\u003c/a> of 21 stroke patients found that they recovered more mobility after they received an injection of donor stem cells into their brains.\u003c/p>\n\u003cp>On transcranial laser devices, the evidence is mixed. The approach has been shown to stimulate neuron growth in some animal studies. However, a high-profile Phase 3 study of one such device in humans was \u003ca href=\"http://stroke.ahajournals.org/content/45/11/3187.long\" target=\"_blank\" rel=\"noopener noreferrer\">halted\u003c/a> in 2014 after it showed no effect on 600 patients’ physical capabilities as they recovered from a stroke. \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02645578?term=right+median+nerve+stimulation&rank=1\" target=\"_blank\" rel=\"noopener noreferrer\">Other\u003c/a> \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02645578\" target=\"_blank\" rel=\"noopener noreferrer\">trials\u003c/a> to revive people from comas using laser therapy are underway.\u003c/p>\n\u003cp>The literature around electrical stimulation of the median nerve — which branches from the spinal cord down the arm and to the fingers — primarily consists of case studies. Dr. Ed Cooper wrote some of those papers, one of which described dozens of patients treated in his home state of North Carolina, including 12 who had a Glasgow Coma Score of 4 — an extremely low score on the scale. With time (and with the nerve stimulation), four of those 12 people made a “good recovery,” the paper described; others were left with minor or major disabilities after their coma.\u003c/p>\n\u003cp>But Cooper, an orthopedic surgeon by training who worked with neurosurgeons on the paper, said unequivocally that there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem — one of the structures that most motor neurons go through before connecting with the cortex proper. If there’s no functional brain stem, then it can’t work.\u003c/p>\n\u003cp>Pastor agreed — but he claimed the technique would work because there are “a small nest of cells” that still function in patients who are brain-dead.\u003c/p>\n\u003cp>Complicating such trials, there is no clear-cut confirmatory test for brain death — meaning a recovery in the trial might not be entirely due to the treatment. Some poisons and drugs, for instance, can make people look brain-dead. Bioquark plans to rely on local physicians in the trial’s host country to make the declaration. “We’re not doing the confirmatory work ourselves,” Pastor said, but each participant would have undergone a battery of tests considered appropriate by local authorities.\u003c/p>\n\u003cp>But a \u003ca href=\"http://www.neurology.org/content/74/23/1911.full\" target=\"_blank\" rel=\"noopener noreferrer\">survey of 38 papers\u003c/a> published over 13 years found that, if the American Academy of Neurology guidelines for brain death had been met, no brain-dead people have ever regained brain function.\u003c/p>\n\u003cp>Of Bioquark’s full protocol, “it’s not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero,” said Dr. Charles Cox, a pediatric surgeon who \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT00254722?term=stem+cell+brain&rank=10\" target=\"_blank\" rel=\"noopener noreferrer\">has done research\u003c/a> with mesenchymal stem cells — the type used in the trial — at the University of Texas Health Science Center at Houston. Cox is not involved in Bioquark’s work.\u003c/p>\n\u003cp>Some studies have found that cells from a part of the brain called the subventricular zone can grow in culture even after a person is declared dead, Cox said. However, it’s unlikely that the trial’s intended outcome — to have a stem cell treatment result in new neurons or connections — would actually happen. Neurons would likely struggle to survive, because blood flow to the brain is almost always lost in people who have been declared brain-dead, Cox said.\u003c/p>\n\u003cp>But Pastor thinks Bioquark’s protocol will work. “I give us a pretty good chance,” he said. “I just think it’s a matter of putting it all together and getting the right people and the right minds on it.”\u003c/p>\n\u003cp>Cox is less optimistic. “I think [someone reviving] would technically be a miracle,” he said. “I think the pope would technically call that a miracle.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This story was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/401647/company-want-to-bring-the-dead-back-to-life-no-really","authors":["byline_futureofyou_401647"],"categories":["futureofyou_1062","futureofyou_1"],"tags":["futureofyou_680"],"featImg":"futureofyou_408533","label":"futureofyou"},"futureofyou_355667":{"type":"posts","id":"futureofyou_355667","meta":{"index":"posts_1591205157","site":"futureofyou","id":"355667","score":null,"sort":[1490289024000]},"guestAuthors":[],"slug":"strong-stem-cell-therapy-results-for-paralyzed-patients-company-says","title":"Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says","publishDate":1490289024,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>A small stem cell trial in which patients with severe spinal injuries appeared to make remarkable progress is still showing excellent results, according to the company conducting the research.\u003c/p>\n\u003caside class=\"pullquote alignright\">'This is as good as you could hope at this point.' \u003ccite>Charles Liu, director of the USC Neurorestoration Center\u003c/cite>\u003c/aside>\n\u003cp>\u003cspan style=\"font-weight: 400\">One of the patients in the trial is 21-year-old Kris Boesen, from Bakersfield, California, whose \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/12/stem-cells-may-have-restored-use-of-hands-and-arms-in-paralyzed-man/\" target=\"_blank\" rel=\"noopener\">story \u003c/a>we reported on last year. A car crash had left the Bakersfield, California native with \u003c/span>\u003cspan style=\"font-weight: 400\">three crushed vertebrae, almost no feeling below his neck, and a grim\u003c/span>\u003cspan style=\"font-weight: 400\"> prognosis. Doctors believed he would live the rest of his life as a paraplegic.\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan style=\"font-weight: 400\">Enter stem cell therapy. Most treatments for serious spinal injuries concentrate on physical therapy to expand the range of the patient's remaining motor skills and to limit further injury, not to reverse the actual damage. But last April, as part of an experimental phase 2 clinical trial called \u003c/span>\u003ca href=\"http://www.scistar-study.com/\" target=\"_blank\" rel=\"noopener\">\u003cspan style=\"font-weight: 400\">SCiStar\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\">, researchers injected Boesen with 10 million stem cells. By July, he had recovered use of his hands to the point where he could use a wheelchair, a computer and a cellphone, and could take care of most of his daily living needs.\u003c/span> In recent months his progress has continued, says his father.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It’s certainly interesting, but it’s still early.'\u003ccite>Paul Knoepfler, UC Davis stem cell researcher\u003c/cite>\u003c/aside>\n\u003cp>Boesen is not the only patient to have improved in the trial, according to Asterias Biotherapeutics, which is conducting the research. Boesen is part of a cohort of six patients who were experiencing various levels of paralysis and were injected with the 10 million stem cell dose. In a Jan. 24 \u003ca href=\"http://asteriasbiotherapeutics.com/presentations/Asterias-Biotherapeutics_Investor_Presentation_January-2017.pdf\" target=\"_blank\" rel=\"noopener\">\u003cspan style=\"font-weight: 400\">update\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\">, the company said\u003c/span>\u003cspan style=\"font-weight: 400\"> five of those patients had improved either one or two levels on a widely used scale to measure \u003c/span>motor function in spinal injury patients.\u003c/p>\n\u003cp class=\"p1\">\u003cspan style=\"font-weight: 400\">On Tuesday, Asterias issued a new \u003c/span>\u003ca href=\"https://finance.yahoo.com/news/full-six-patient-cohort-confirms-110000936.html\" target=\"_blank\" rel=\"noopener\">\u003cspan style=\"font-weight: 400\">update\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\">,\u003c/span> \u003cspan style=\"font-weight: 400\">announcing\u003c/span> \u003cspan style=\"font-weight: 400\"> that the sixth patient in the cohort has experienced a similar improvement. \u003c/span>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">While spontaneous recovery for spinal injury patients does occur, the likelihood of all six patients recovering to the degree they have is less likely, researchers say.\u003c/p>\n\u003cp class=\"p1\">“This is as good as you could hope at this point,” said Charles Liu, Boesen’s neurosurgeon and director of the USC Neurorestoration Center. “So far all the evidence is pointing in the right direction.”\u003c/p>\n\u003cp class=\"p1\">To measure improvement in spinal injury patients, researchers use two yardsticks: the Upper Extremity Motor Scale, or UEMS, and the International Standards for Neurological Classification of Spinal Cord Injury, or ISNCSCI. On the UEMS scale, patients are scored from 0 to 5 on their ability to use \u003ca href=\"http://www.nature.com/sc/journal/v45/n3/fig_tab/3102008t1.html\" target=\"_blank\" rel=\"noopener\">five key muscles\u003c/a> in the wrists, elbows and fingers. The \u003ca href=\"http://www.hopkinsmedicine.org/healthlibrary/conditions/physical_medicine_and_rehabilitation/spinal_cord_injury_85,P01180/\" target=\"_blank\" rel=\"noopener\">ISNCSCI scale\u003c/a> assesses where damage has occurred along the different levels of the cervical vertebrae, which generally determines the scope of impairment to the body and the\u003ca href=\"http://www.spinalinjury101.org/details/levels-of-injury\" target=\"_blank\" rel=\"noopener\"> level of care needed\u003c/a>.\u003c/p>\n\u003cp>For instance, if a patient has sustained damage at the fourth cervical vertebra down, known as C-4, at the base of the neck, it generally means that person is paralyzed from the neck down, requiring round-the-clock care and a ventilator to breathe. A patient with a C-5 injury may not be able to move her arms or hands, requiring about 6 to 12 hours per day of assisted care; and at the C-6 level, better motor function may allow a patient to take care of most of her daily living needs on her own.\u003c/p>\n\u003cfigure id=\"attachment_243385\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-243385 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/09/Neurosurgery-Stem-Cell-spine-patient-Kris-Boesen_04-800x526.jpg\" alt=\"Lifting weights is part of Kris Boesen’s regular program of physical therapy. \" width=\"800\" height=\"526\">\u003cfigcaption class=\"wp-caption-text\">Lifting weights is part of Kris Boesen’s regular program of physical therapy. \u003ccite>(Greg Iger/Keck Medicine of USC))\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Which is all to say that even one level of recovery could substantially improve the daily life of a spinal injury patient.\u003c/p>\n\u003cp class=\"p1\">According to Asterias, all six patients in the 10 million-cell cohort have improved their general UEMS scores, and jumped at least one motor level on the ISNCSCI scale on one or both sides of their body.\u003c/p>\n\u003cp class=\"p1\">Two patients have improved two motor levels on one side; and one patient, Boesen, has improved two motor levels on both sides\u003cb>. \u003c/b>\u003c/p>\n\u003cp>Steve Cartt, president and CEO of Asterias, said another patient, Jake Javier of Danville, California, has gone from partial paralysis to being able to use his hands well enough to consider pursuing a computer science career.\u003c/p>\n\u003cp>\u003cstrong>'Throws Like a Regular Throw'\u003c/strong>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">In September, Boesen’s father, Rod Boesen, told us how excited he was that his son had regained some feeling in one of his feet. Last week, at 11 months post-injection, the elder Boesen said Kris has continued to improve.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">“Now he can move his toe and his knee together at the same time,” Boesen said. “They’re about to give him a manual wheelchair now [instead of a motorized one]. He can grip with his hands enough to use a manual one.”\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">Boesen said the movement in his son’s arms and hands has greatly improved since September. \u003c/span>\u003cspan style=\"font-weight: 400\">Kris, a former high school pitcher, had been flinging a ball to his dog “like people throw hand grenades,” Boesen said. “They kind of cradle them – and that’s how Kris would do it. … But now he throws like a regular throw, tosses that ball down the hall, has that release point down, and just wings it.”\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">Asterias is currently recruiting patients for a trial in which they'll receive 20 million stem cells, the optimal dose, according to company researchers. T\u003c/span>\u003cspan style=\"font-weight: 400\">wo patients have already started the 20 million stem cell therapy, and six-month results from those patients will be released in the fall, Cartt said.\u003c/span>\u003c/p>\n\u003cp>Patients who received 2 million stem cells in an earlier phase of the study have not shown much change in their condition, according to the Jan. 24 update.\u003c/p>\n\u003cp>\u003cstrong>Guarded Optimism\u003c/strong>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">While Boesen’s father is impressed with the results, the optimism of researchers inside and outside the study has been guarded. \u003c/span>The trial is still in its early stages, and the sample size is small, said Paul Knoepfler, a cell biology professor and stem cell researcher at UC Davis, who is not involved in the SCiStar study.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">\"As a scientist, I still would want to wait for more data,” Knoepfler said. “It’s certainly interesting, but it’s still early. It’s a phase 2 trial.”\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan style=\"font-weight: 400\">To address the issue of small sample size, Asterias is looking at historical data to determine the level of improvement for patients in similar circumstances who did not receive stem cell therapy. The company has said it found \"a meaningful difference\" in the recovery of its study patients compared to the norm. \u003c/span>\u003c/p>\n\u003cp class=\"p1\">Liu said one of the most important results is the lack of significant side effects or other negative outcomes resulting from the treatment to date.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">\"That’s very significant to me,” Liu said. “That’s the first thing you look for, is anyone hurt from this therapy.”\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">There was also a concern, he said, that some patients might regress over time, once the initial injection of stem cells wore off. That has yet to occur.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">“No one has lost anything they’ve gained,” Liu said. “We were very happy to see that. This is all very promising.\"\u003c/span>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">The next step for the SCiStar trial will be to establish a control group, Cartt said.\u003c/span>\u003c/p>\n\n","blocks":[],"excerpt":"Among the patients injected with 10 million stem cells is Kris Boesen, who suffered three crushed vertebrae in a car accident last year and was thought by doctors to have little hope of recovery.","status":"publish","parent":0,"modified":1508865852,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":1290},"headData":{"title":"Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says | KQED","description":"Among the patients injected with 10 million stem cells is Kris Boesen, who suffered three crushed vertebrae in a car accident last year and was thought by doctors to have little hope of recovery.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says","datePublished":"2017-03-23T17:10:24.000Z","dateModified":"2017-10-24T17:24:12.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"355667 https://ww2.kqed.org/futureofyou/?p=355667","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/03/23/strong-stem-cell-therapy-results-for-paralyzed-patients-company-says/","disqusTitle":"Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says","source":"KQED Future of You","path":"/futureofyou/355667/strong-stem-cell-therapy-results-for-paralyzed-patients-company-says","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>A small stem cell trial in which patients with severe spinal injuries appeared to make remarkable progress is still showing excellent results, according to the company conducting the research.\u003c/p>\n\u003caside class=\"pullquote alignright\">'This is as good as you could hope at this point.' \u003ccite>Charles Liu, director of the USC Neurorestoration Center\u003c/cite>\u003c/aside>\n\u003cp>\u003cspan style=\"font-weight: 400\">One of the patients in the trial is 21-year-old Kris Boesen, from Bakersfield, California, whose \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/12/stem-cells-may-have-restored-use-of-hands-and-arms-in-paralyzed-man/\" target=\"_blank\" rel=\"noopener\">story \u003c/a>we reported on last year. A car crash had left the Bakersfield, California native with \u003c/span>\u003cspan style=\"font-weight: 400\">three crushed vertebrae, almost no feeling below his neck, and a grim\u003c/span>\u003cspan style=\"font-weight: 400\"> prognosis. Doctors believed he would live the rest of his life as a paraplegic.\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan style=\"font-weight: 400\">Enter stem cell therapy. Most treatments for serious spinal injuries concentrate on physical therapy to expand the range of the patient's remaining motor skills and to limit further injury, not to reverse the actual damage. But last April, as part of an experimental phase 2 clinical trial called \u003c/span>\u003ca href=\"http://www.scistar-study.com/\" target=\"_blank\" rel=\"noopener\">\u003cspan style=\"font-weight: 400\">SCiStar\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\">, researchers injected Boesen with 10 million stem cells. By July, he had recovered use of his hands to the point where he could use a wheelchair, a computer and a cellphone, and could take care of most of his daily living needs.\u003c/span> In recent months his progress has continued, says his father.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It’s certainly interesting, but it’s still early.'\u003ccite>Paul Knoepfler, UC Davis stem cell researcher\u003c/cite>\u003c/aside>\n\u003cp>Boesen is not the only patient to have improved in the trial, according to Asterias Biotherapeutics, which is conducting the research. Boesen is part of a cohort of six patients who were experiencing various levels of paralysis and were injected with the 10 million stem cell dose. In a Jan. 24 \u003ca href=\"http://asteriasbiotherapeutics.com/presentations/Asterias-Biotherapeutics_Investor_Presentation_January-2017.pdf\" target=\"_blank\" rel=\"noopener\">\u003cspan style=\"font-weight: 400\">update\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\">, the company said\u003c/span>\u003cspan style=\"font-weight: 400\"> five of those patients had improved either one or two levels on a widely used scale to measure \u003c/span>motor function in spinal injury patients.\u003c/p>\n\u003cp class=\"p1\">\u003cspan style=\"font-weight: 400\">On Tuesday, Asterias issued a new \u003c/span>\u003ca href=\"https://finance.yahoo.com/news/full-six-patient-cohort-confirms-110000936.html\" target=\"_blank\" rel=\"noopener\">\u003cspan style=\"font-weight: 400\">update\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\">,\u003c/span> \u003cspan style=\"font-weight: 400\">announcing\u003c/span> \u003cspan style=\"font-weight: 400\"> that the sixth patient in the cohort has experienced a similar improvement. \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp class=\"p1\">While spontaneous recovery for spinal injury patients does occur, the likelihood of all six patients recovering to the degree they have is less likely, researchers say.\u003c/p>\n\u003cp class=\"p1\">“This is as good as you could hope at this point,” said Charles Liu, Boesen’s neurosurgeon and director of the USC Neurorestoration Center. “So far all the evidence is pointing in the right direction.”\u003c/p>\n\u003cp class=\"p1\">To measure improvement in spinal injury patients, researchers use two yardsticks: the Upper Extremity Motor Scale, or UEMS, and the International Standards for Neurological Classification of Spinal Cord Injury, or ISNCSCI. On the UEMS scale, patients are scored from 0 to 5 on their ability to use \u003ca href=\"http://www.nature.com/sc/journal/v45/n3/fig_tab/3102008t1.html\" target=\"_blank\" rel=\"noopener\">five key muscles\u003c/a> in the wrists, elbows and fingers. The \u003ca href=\"http://www.hopkinsmedicine.org/healthlibrary/conditions/physical_medicine_and_rehabilitation/spinal_cord_injury_85,P01180/\" target=\"_blank\" rel=\"noopener\">ISNCSCI scale\u003c/a> assesses where damage has occurred along the different levels of the cervical vertebrae, which generally determines the scope of impairment to the body and the\u003ca href=\"http://www.spinalinjury101.org/details/levels-of-injury\" target=\"_blank\" rel=\"noopener\"> level of care needed\u003c/a>.\u003c/p>\n\u003cp>For instance, if a patient has sustained damage at the fourth cervical vertebra down, known as C-4, at the base of the neck, it generally means that person is paralyzed from the neck down, requiring round-the-clock care and a ventilator to breathe. A patient with a C-5 injury may not be able to move her arms or hands, requiring about 6 to 12 hours per day of assisted care; and at the C-6 level, better motor function may allow a patient to take care of most of her daily living needs on her own.\u003c/p>\n\u003cfigure id=\"attachment_243385\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-243385 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/09/Neurosurgery-Stem-Cell-spine-patient-Kris-Boesen_04-800x526.jpg\" alt=\"Lifting weights is part of Kris Boesen’s regular program of physical therapy. \" width=\"800\" height=\"526\">\u003cfigcaption class=\"wp-caption-text\">Lifting weights is part of Kris Boesen’s regular program of physical therapy. \u003ccite>(Greg Iger/Keck Medicine of USC))\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Which is all to say that even one level of recovery could substantially improve the daily life of a spinal injury patient.\u003c/p>\n\u003cp class=\"p1\">According to Asterias, all six patients in the 10 million-cell cohort have improved their general UEMS scores, and jumped at least one motor level on the ISNCSCI scale on one or both sides of their body.\u003c/p>\n\u003cp class=\"p1\">Two patients have improved two motor levels on one side; and one patient, Boesen, has improved two motor levels on both sides\u003cb>. \u003c/b>\u003c/p>\n\u003cp>Steve Cartt, president and CEO of Asterias, said another patient, Jake Javier of Danville, California, has gone from partial paralysis to being able to use his hands well enough to consider pursuing a computer science career.\u003c/p>\n\u003cp>\u003cstrong>'Throws Like a Regular Throw'\u003c/strong>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">In September, Boesen’s father, Rod Boesen, told us how excited he was that his son had regained some feeling in one of his feet. Last week, at 11 months post-injection, the elder Boesen said Kris has continued to improve.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">“Now he can move his toe and his knee together at the same time,” Boesen said. “They’re about to give him a manual wheelchair now [instead of a motorized one]. He can grip with his hands enough to use a manual one.”\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">Boesen said the movement in his son’s arms and hands has greatly improved since September. \u003c/span>\u003cspan style=\"font-weight: 400\">Kris, a former high school pitcher, had been flinging a ball to his dog “like people throw hand grenades,” Boesen said. “They kind of cradle them – and that’s how Kris would do it. … But now he throws like a regular throw, tosses that ball down the hall, has that release point down, and just wings it.”\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">Asterias is currently recruiting patients for a trial in which they'll receive 20 million stem cells, the optimal dose, according to company researchers. T\u003c/span>\u003cspan style=\"font-weight: 400\">wo patients have already started the 20 million stem cell therapy, and six-month results from those patients will be released in the fall, Cartt said.\u003c/span>\u003c/p>\n\u003cp>Patients who received 2 million stem cells in an earlier phase of the study have not shown much change in their condition, according to the Jan. 24 update.\u003c/p>\n\u003cp>\u003cstrong>Guarded Optimism\u003c/strong>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">While Boesen’s father is impressed with the results, the optimism of researchers inside and outside the study has been guarded. \u003c/span>The trial is still in its early stages, and the sample size is small, said Paul Knoepfler, a cell biology professor and stem cell researcher at UC Davis, who is not involved in the SCiStar study.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">\"As a scientist, I still would want to wait for more data,” Knoepfler said. “It’s certainly interesting, but it’s still early. It’s a phase 2 trial.”\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan style=\"font-weight: 400\">To address the issue of small sample size, Asterias is looking at historical data to determine the level of improvement for patients in similar circumstances who did not receive stem cell therapy. The company has said it found \"a meaningful difference\" in the recovery of its study patients compared to the norm. \u003c/span>\u003c/p>\n\u003cp class=\"p1\">Liu said one of the most important results is the lack of significant side effects or other negative outcomes resulting from the treatment to date.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">\"That’s very significant to me,” Liu said. “That’s the first thing you look for, is anyone hurt from this therapy.”\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">There was also a concern, he said, that some patients might regress over time, once the initial injection of stem cells wore off. That has yet to occur.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">“No one has lost anything they’ve gained,” Liu said. “We were very happy to see that. This is all very promising.\"\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">The next step for the SCiStar trial will be to establish a control group, Cartt said.\u003c/span>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/355667/strong-stem-cell-therapy-results-for-paralyzed-patients-company-says","authors":["8656"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1367","futureofyou_80","futureofyou_1221","futureofyou_1222","futureofyou_1010","futureofyou_680"],"featImg":"futureofyou_242691","label":"source_futureofyou_355667"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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