Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?
Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says
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Cell","publishDate":1473526343,"status":"inherit","parent":242687,"modified":1489697206,"caption":"Kris Boesen in 2016, after doctors at Keck Medical Center of USC injected 10 million stem cells into his damaged spine as part of a multisite clinical trial.","credit":"Greg Iger/Keck Medicine of USC)","description":"Shortly after doctors at Keck Medical Center of USC injected 10 million stem cells into his spine as part of a multi-site clinical trial, Kris Boesen began to show signs of 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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_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. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. 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You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED MindShift: How We Will Learn","officialWebsiteLink":"/mindshift/","meta":{"site":"news","source":"kqed","order":"2"},"link":"/podcasts/mindshift","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/mindshift-podcast/id1078765985","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5","npr":"https://www.npr.org/podcasts/464615685/mind-shift-podcast","stitcher":"https://www.stitcher.com/podcast/kqed/stories-teachers-share","spotify":"https://open.spotify.com/show/0MxSpNYZKNprFLCl7eEtyx"}},"morning-edition":{"id":"morning-edition","title":"Morning Edition","info":"\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. 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On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. 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