The FDA recently cracked down on two stem cell clinics for questionable research practices, including one clinic that was using smallpox vaccine as part of a treatment protocol.

The FDA took action to prevent the use of “a potentially dangerous and unproven treatment” belonging to StemImmune Inc. in San Diego, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, according to an FDA report of the incident.1

On, Aug. 25, 2017, the FDA seized five vials of Vaccinia virus vaccine, a live vaccine indicated only for the military, lab researchers, and some healthcare workers. The vaccine is primarily to protect against a bioterrorism attack, as smallpox has been eradicated in the wild for decades.

“Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact,” according to the report. “As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.”

FDA Commissioner Scott Gottlieb, MD, issued a personal statement, saying that as a cancer survivor he knows “all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious, but ultimately hollow, claims made by these kinds of unscrupulous clinics. … 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.”

Apparently, the vaccine was used to create an unapproved stem cell product — a combination of amounts of vaccine and stem cells derived from body fat, the FDA reported.

“[The product] was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis,” the FDA reported. “The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.”

Gottlieb urged healthcare providers, patients, and consumers to report these kinds of activities or any adverse events associated with these unproven treatments.

The FDA also issued a warning letter2 to U.S. Stem Cell Clinic of Sunrise, FL, for “marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, and put patients at risk.”

The FDA recently inspected U.S. Stem Cell Clinic and found that the clinic was processing stem cells derived from body fat and administering them to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and chronic obstructive pulmonary disease (COPD).

“The FDA has not reviewed or approved any biological products manufactured by U.S. Stem Cell Clinic for any use,” the agency stated.

The FDA further charged in its report that U.S. Stem Cell Clinic tried to impede its investigation by refusing to allow entry except by appointment and by denying FDA investigators access to employees.

“Refusing to permit entry or FDA inspection is a violation of federal law,” according to the report.

The FDA has requested a response from U.S. Stem Cell Clinic, including a statement of how the deviations noted in the warning letter will be corrected, within 15 working days.

A critic of stem cell operations marketing questionable treatments welcomed the news, but wondered if FDA would follow through beyond the rhetoric.

“I really think it depends on what happens over the next several months or several years,” says Leigh Turner, PhD, who recently warned that some stem cell clinics are charging research subjects exorbitant fees for participation in experimental treatments marketed as clinical trials on ClinicalTrials.gov.

“There are a number of things that have gone on to increase FDA’s enforcement activity in this area,” says Turner, a professor in the Center for Bioethics at the University of Minnesota in Minneapolis.

“I say that just because there was a fairly forceful announcement from Scott Gottlieb suggesting that the FDA plans on dealing with what they describe as the few ‘bad actors’ that are out there,” he says.

Still, Turner questions if the FDA has fired a warning shot over the bow or has begun a comprehensive enforcement effort that will continue with subsequent investigations.

“Are we are going to see a significant increase in warning letters, other forms of regulatory action, or do we have this announcement and then a minor uptick in enforcement activity — and that’s it?” he asks. “If it’s the latter, then I don’t expect to see any major changes in the marketplace. I think it all comes down to what extent is this mostly rhetoric and to what extent is it the FDA staking out what they are going to do and then actually providing some oversight for the marketplace. It’s difficult to predict.”

REFERENCES

  1. Food and Drug Administration. FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients. August 28, 2017. Available at: http://bit.ly/2wC1DMU.
  2. Food and Drug Administration. FDA warns US Stem Cell Clinic of significant deviations. August 28, 2017. Available at: http://bit.ly/2wiyVxK.