FDA Injunctions Send Clear Message: Stem Cell Clinics Beware

 (Kathrin Plath lab/UCLA, via CIRM, NIH)

The Food and Drug Administration is getting serious about reining in stem cell clinics. On Wednesday, the agency announced it wants to bar two of the largest clinic networks in the country from marketing their treatments, which would effectively halt their operations.

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 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.

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.

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.

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.

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“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.

 

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