The US safety agency announced a more stringent oversight on stem-cell clinics to prevent the use of unapproved treatments in human subjects.
A warning letter was sent to Stem Cell Clinic of Sunrise, Florida, for the marketing and administration of stem cell products without FDA approval. Furthermore, the FDA accused the clinic of not observing stringent manufacturing requirements, thereby compromising the sterility and safety of the product. Such negligent practice, the FDA said, could significantly jeopardize patients’ lives.
“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 Scott Gottlieb, FDA Commissioner. “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.”
During the inspection of Stem Cell Clinic, FDA investigators found numerous infractions. The clinic was injecting stem cells derived from body fat either intravenously or directly into patients’ spinal cord, claiming the procedure treated Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), and heart disease. Not only are there no scientific evidence to support such treatments in these serious and chronic conditions, but the treatments were given to patients without ever going through FDA review or approval.
In addition to conducting treatments on people without authorization, FDA investigators also cited the clinic for not following sterile protocols. These deviations increase the risk for microbiological contamination, putting patients at risk for infections. Lastly, the clinic was cited for not fully cooperating with FDA investigators. No doubt, this last infraction was the clinic’s last ditch effort to hide more evidence that they themselves already know to be unscrupulous.
In addition to US Stem Cell Clinic at Sunrise, Florida, the FDA also cracked down on another facility, StemImmune, based in San Diego, California. According to the FDA, US Marshals Service acted on their behalf and seized five vials of a live smallpox virus vaccine that was combined with fat-derived stem cells. The company intended to inject this highly dangerous and unapproved product into seriously ill cancer patients, per the FDA.
Notably, the seized smallpox vaccine is not commercially available, and is reserved for people at high risk of smallpox, such as active military members. The agency is currently investigating exactly how StemImmune procured this vaccine. While the vaccine can’t cause smallpox, exposing people with compromised immune systems could lead to life-threatening complications, including myocarditis (swelling of the heart).
“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,” said Gottlieb.
“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,” he said.
The FDA hopes to tighten the marketing of stem cell treatments. Currently, the only FDA approved stem cell-based treatment involves cord blood-derived cells.
“I’ve directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk,” Gottlieb said. “I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.”