FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

https://www.fda.gov/news-events/press-announcements/fda-sends-warning-company-selling-unapproved-umbilical-cord-blood-and-umbilical-cord-products-may?utm_campaign=090319_PR_FDA%20sends%20warning%20letter%20to%20company%20for%20marketing%20unapproved%20stem%20cell&utm_medium=email&utm_source=Eloqua

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

Stemell sold stem cell products without required FDA approval

The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices and environmental monitoring, creating potential significant safety concerns that put patients at risk. Stemell’s unapproved products derived from umbilical cord blood and umbilical cord are StemL UCB-Plus and StemL UCT-Plus. “We know that there are manufacturers and clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don't fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true,” said Acting FDA Commissioner Ned Sharpless, M.D. “This company failed to...

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