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FDA moves against unproven treatments at stem cell centers

The agency raided two stem cell centers in California on Friday and has issued a warning to one in Florida for possibly dangerous medical treatments.

By Amy Wallace
FDA moves against unproven treatments at stem cell centers
The U.S. Food and Drug Administration along with the U.S. Marshals Service seized an unproven and potentially harmful stem cell treatment from centers in California on Friday, and the FDA today sent a warning letter to a clinic in Florida for also offering potentially harmful treatments. Photo by PublicDomainPictures/PixaBay

Aug. 28 (UPI) -- The U.S. Food and Drug Administration has announced moves against unproven and possibly dangerous stem cell treatments, raiding two stem cell centers in California on Friday and has issuing a warning to one in Florida today.

"As the agency responsible for ensuring these therapies are safe and effective, I will not allow these activities to go unchecked," Dr. Scott Gottlieb, commissioner of the FDA, said Monday in a statement. "I've directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health."

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U.S. Marshals on behalf of the FDA seized five vials of the Vaccinia Virus Vaccine (Live), for use only in smallpox, from stem cell centers in California Friday as part of a larger effort to crack down on illegal stem cell clinics.

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The seizure was made because the virus is being used as an unproven and potentially dangerous treatment from StemImmune Inc., and has been administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.

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The Vaccinia Virus Vaccine is reserved for people at high risk for smallpox such as some members of the military. The vaccine is not approved by the FDA for commercial use and has caused serious concerns in relation to how StemImmune obtained the vaccine for use as part of an unapproved and potentially dangerous stem cell treatment.

"Speaking as a cancer survivor, I know 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 or others selling so-called cures," Gottlieb, said in a press release.

"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. 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."

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The agency found through inspections that StemImmune Inc., and the California Stem Cell Treatment Centers was using the vaccine to create an unapproved stem cell product, a combination of excess amounts of vaccine and stromal vascular fraction, which are stem cells derived from body fat.

The unapproved stem cell product was then given to cancer patients with potentially compromised immune systems, although the vaccine presents potential harm -- including inflammation of the heart and heart tissue. The treatment was injected intravenously and directed into patients' tumors.

The FDA today also issued a warning letter to the U.S. Stem Cell Clinic of Sunrise, Fla., and Kristen Comella, its chief scientific officer, for marketing stem cell products without FDA approval. The clinic was also warned for significant deviations from current good manufacturing practice requirements including some that could impact the sterility of their products.

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FDA investigators cited U.S. Stem Cell Clinic for failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile and the clinic allegedly tried to impede the investigation by not allowing entry except by appointment and by denying FDA inspectors access to employees, both of which are violations of federal law.

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"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," Gottlieb said.

"As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit."

Gottlieb said he has directed the agency to investigate "unscrupulous clinics" using all tools available to the agency, and urged healthcare providers, patients and consumers to report either the availability of such treatments or adverse health events to the FDA through MedWatch.

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