Regulators step in to stop stem cell clinics from marketing unproven therapies
James Strachan |
The FDA has filed two complaints in federal court to stop two clinics from marketing stem cell products without FDA approval and for “significant deviations from current good manufacturing practice (GMP) requirements” (1).
A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella, and its co-owner and managing officer Theodore Gradel. The FDA accused the clinic of potentially putting patients at risk by failing to ensure the sterility of their products. The clinic processes adipose tissue into stem cells, which they administer (intravenously or directly) into the spinal cord of patients with a variety of serious conditions, including Parkinson’s, spinal cord injuries and heart disease. The FDA issued a warning letter to the clinic in August last year, after documenting during an inspection “significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products.” US Stem Cell Clinic also tried to impede the FDA’s investigation during the most recent inspection by refusing entry except by appointment and by denying investigators access to employees.
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