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# U.S. Stem Cell Defends Practices in Appeals Court
- URL: https://www.fdaweb.com/u-s-stem-cell-defends-practices-in-appeals-court/
- Published: 2021-01-19T12:00:00.000Z
- Updated: 2026-09-14T16:43:13.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148480

U.S. Stem Cell, Inc., Sunrise, FL, says it argued 1/13 before the 11th Circuit Court of Appeals that it should be allowed to present evidence and testimony in support of its position and practices in a trial. The [case](https://finance.yahoo.com/news/usrm-oral-argument-appeal-fda-182000081.html?guccounter=1&ref=fdaweb.com) involves a 5/9/18 FDA suit against the company and other similar firms to prevent them from using the stromal vascular fraction (SVF) surgical procedure in which cells are removed from a patient’s fat tissue and reimplanted in the patient during the same surgical procedure.

The company maintains that such cellular therapies are surgical procedures regulated by state law and that the SVF procedure is excepted from regulation under the Federal Food, Drug, and Cosmetic Act.

A Florida federal court ruled in favor of the government on 6/25/19 and U.S. Stem Cell appealed on 8/23/19.

Before the 11th Circuit, company attorneys argued that the SVF procedure is not subject to regulation under a 2001 FDA rule that provides an exception for a procedure in which cells are removed from and implanted in the same patient during the same surgical procedure. FDA has argued, the company says, that the exception does not apply because the reimplanted cells are not in their original form.