The U.S. government has scored a major victory against a for-profit stem cell company in its efforts to regulate the use of unproven and unapproved stem cell therapy for certain medical conditions. Federal judge Ursula Ungaro has ruled that the FDA has the authority to regulate the use of patients’ fat to create a stem cell treatment after at least four patients have been blinded by the treatment.
According to the Washington Post, the judge ruled that the FDA is entitled to an injunction that orders U.S. Stem Cell to stop offering the procedure. “This decision says the FDA has the authority to define a certain kind of stem cell product as a drug product” that requires FDA approval and compliance with other agency rules, said Paul Knoepfler, a stem cell biologist at the University of California at Davis. “There are potentially hundreds of clinics using the same model, and this ruling basically says the FDA can — assuming this is not overturned on appeal — say you are using an unapproved drug, and that’s a big deal.”
“In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in a news release. “We are committed to continuing to pursue actions against those who put patients in harm’s way by marketing unapproved stem cell products that skirt FDA’s regulations and federal law.”
U.S. Stem Cell has issued a written statement saying, “While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision.” The Washington Post reports that a spokeswoman for U.S. Stem Cell “plans to continue offering stem cell treatments derived from bone-marrow and amniotic tissue”.