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# Appeals Court Backs FDA in Stem Cell Case
- URL: https://www.fdaweb.com/appeals-court-backs-fda-in-stem-cell-case/
- Published: 2021-06-03T12:00:00.000Z
- Updated: 2026-09-14T17:01:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149456

The 11th Circuit Court of Appeals has upheld a Florida federal court decision to grant summary judgment to FDA in its suit alleging that US Stem Cell Clinic, its parent company, and its chief scientific officer are providing stem cell procedures that violate the Federal Food, Drug, and Cosmetic Act. The appeals court [says](https://media.ca11.uscourts.gov/opinions/pub/files/201913276.pdf?ref=fdaweb.com) the company procedure involved removing fat tissue from a patient, isolating the portion containing stem cells, and injecting that portion back into the patient, purportedly to treat many chronic conditions, from pain to Parkinson’s disease.

The district court enjoined the clinic from offering its procedure until it demonstrated to FDA that the therapy is safe and effective.

In its appeal, the clinic maintained that it is exempt from regulation because its procedure falls into one of two exceptions in the law.

“We disagree,” a three-judge appeals court panel wrote. “The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed, and the procedure does not fall within the second exception because the clinic intends the stem cells to perform functions after the procedure beyond the basic function the stem cells performed prior to the procedure.”