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FDA cracks down on “unproven” stem cell treatments



The U.S. Food and Drug Administration took what it called “decisive action to prevent the use of a potentially dangerous and unproven treatment” belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on August 25, the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine; one vial was partially used, four were intact.

In a press release issued by the FDA it stated, “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.”

The release went on to say that “the seizure comes after recent FDA inspections at StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – stem cells derived from body fat), which 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 (inflammation and swelling of the heart and surrounding tissues). The treatment was being injected intravenously and directly into patients' tumors.”

The U.S. Department of Justice filed the seizure complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California.

The FDA also issued a warning letter to US Stem Cell Clinic of Sunrise, Florida, and its chief scientific officer, Kristin Comella, for “marketing stem cell products without FDA approval” and for what the letter said were “significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.”

“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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

The FDA said that it recently inspected US Stem Cell Clinic and found the clinic was processing adipose tissue (body fat) into stromal vascular fraction (stem cells derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA said it has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use.

“Our aim is to provide an efficient route to market for promising technologies,” Dr. Gottlieb continued. “But at the same time, we will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures. We want a regulatory framework that helps efficiently and effectively advance the many promising technologies in the field of regenerative cell therapies. The FDA can’t allow a small number of bad actors to leverage that promise to mislead patients and put them at risk.”

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