“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.”
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.
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.
Knoepfler has compiled a list 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.”
And the epicenter of that stem cell clinic activity is Southern California, and Beverly Hills in particular, which has 18 clinics, Knoepfler said.
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.
And in November last year, the FDA released tightened rules 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.
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.
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.”
Knoepfler said the issue should not prompt a philosophical debate; it’s simply about patient safety.
“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.”
A Bigger Stick?
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 best-practices guidelines for stem cell clinics. That’s significant because medical boards hold and can withdraw one of the things physicians value most: their medical license.
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.
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.
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.
“Somehow with the medical board license, for physicians it’s more of a tangible thing to take seriously,” Knoepfler said.