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FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.
FDA sent a warning letter, dated Aug. 24, 2017, to US Stem Cell Clinic (Sunrise, FLA) for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice (CGMP) requirements, including some that could impact the sterility of their products and put patients at risk.
FDA inspected US Stem Cell Clinic’s facility between April 10 and May 11, 2017 and found that the clinic was processing adipose tissue (body fat) into stromal vascular fraction (stem cells derived from body fat) and administering the product 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, chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis. FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use.
During the inspection, FDA investigators also documented evidence of significant deviations from CGMPs in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the firm was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.
US Stem Cell Clinic also tried to impede FDA’s investigation during the most recent inspection by refusing to allow entry except by appointment and by denying FDA investigators access to employees. Refusing to permit entry or FDA inspection is a violation of federal law. The agency has requested a response from US Stem Cell Clinic, including a statement of how the deviations noted in the warning letter will be corrected, within 15 working days from receipt of the letter.
“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, MD, in an agency press release. “As [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.”
“Our aim is to provide an efficient route to market for promising technologies,” Dr. Gottlieb said in the release. “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. [FDA] can’t allow a small number of bad actors to leverage that promise to mislead patients and put them at risk.”