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# Federal Court Rules Against U.S. Stem Cell Clinic
- URL: https://www.fdaweb.com/federal-court-rules-against-u-s-stem-cell-clinic/
- Published: 2019-06-04T12:00:00.000Z
- Updated: 2026-09-15T01:30:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144252

A Florida federal court has [granted](https://www.ipscell.com/wp-content/uploads/2019/06/USRM-lawsuit.pdf?ref=fdaweb.com) the federal government’s motion for summary judgment against U.S. Stem Cell Clinic and its chief scientific officer for adulterating and misbranding a stem cell drug product made from a patient’s adipose tissue. The Justice Department initiated legal action against the clinic and its chief scientific officer, **Kristin Comella**, on behalf of FDA after several attempts to provide the clinic and individual defendants the opportunity to work with the agency to come into compliance with FDA regulations, according to an FDA [statement](https://www.fda.gov/news-events/press-announcements/federal-court-issues-decision-holding-us-stem-cell-clinics-and-owner-adulterated-and-misbranded-stem?ref=fdaweb.com).

CBER director **Peter Marks** said the clinic and its leadership “have put patients at serious risk through their disregard of the law and prior FDA warnings.”

In a 2017 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-stem-cell-clinic-llc-524470-08242017?ref=fdaweb.com), FDA said the clinic was marketing stem cell products without FDA approval and cited significant deviations from current good manufacturing practice regulations following an agency inspection that found the company was administering its product intravenously or via other methods of administration to treat a variety of serious diseases or conditions. FDA says it has not approved any biological products manufactured by U.S. Stem Cell Clinic for any use. The clinical also was cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile.

The agency statement says FDA also is seeking a permanent injunction to stop California Stem Cell Treatment Center from marketing to patients cellular products without FDA approval. That litigation is ongoing, it says.