FDA says it will increase stem cell clinic regulation – FDA

This in from Quackwatch. As someone who’s late wife was the victim of a stem cell scam, I am thrilled to hear this news. This is a very real scam, both here and in the Mexican border to southwest of Yuma, which unfortunately won’t be within the reach of the FDA.

FDA Commissioner Scott Gottlieb, M.D., has announced that the FDA “ ill be stepping up 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.” [FDA warns US Stem Cell Clinic of significant deviations. FDA news release, Aug 28, 2017] The agency also posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida and its Chief Scientific Officer, Kristin Comella, for marketing unapproved 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. A recent FDA inspection found that the clinic was processing stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis. In a parallel action, at the FDA’s request, U.S. Marshals seized five vials of live vaccinia virus vaccine that had been used or were awaiting use to create an unapproved stem cell product for cancer patients. The FDA’s announcement noted that this vaccine is reserved only for people at high risk for smallpox (such as some members of the military) and has considerable potential for harm. [FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients. FDA news release, Aug 28, 2017]

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