The U.S. Food and Drug Administration today posted a warning letter issued 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 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 recently inspected US Stem Cell Clinic 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 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 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,” 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.”
During the inspection, FDA investigators also documented evidence of significant deviations from current good manufacturing practices 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 the 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 FDA 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. Companies that do not correct deviations risk additional enforcement action such as seizure, injunction, or prosecutions.
Health care professionals and consumers should report any adverse events related to treatments provided by US Stem Cell Clinic to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.