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FDA seeks permanent injunctions against two stem cell clinics

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The U.S. Food and Drug Administration (FDA) filed complaints in federal court on May 9 seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.

While lauding the potential of stem cell based regenerative medicine, FDA commissioner Scott Gottlieb, M.D., also vowed to take action against clinics “that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use,” he said.

A permanent injunction is being sought against U.S. Stem Cell Clinic LLC of Sunrise, Florida, its chief scientific officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA said it is taking this action because U.S. Stem Cell Clinic “did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law.”

The FDA is seeking an order of permanent injunction requiring U.S. Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Drs. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

In a press release issued the day after the FDA filed its complaints seeking the injunctions, the California Institute for Regenerative Medicine (CIRM), the state’s stem cell agency, commended the US Food and Drug Administration (FDA) for its action against two stem cell clinics.

 

Learn more:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm

https://www.cirm.ca.gov/about-cirm/newsroom/press-releases/05102018/california%E2%80%99s-stem-cell-agency-applauds-fda-crackdown