FDA stem cells

FDA stem cell court cases total 215, of which 178 are federal court decisions concerning the FDA and stem cells. Of these, the FDA was a party in only a few of them, all in federal court.

At the U.S. Court of Appeals, there have been very few decisions concerning the extent of FDA authority over this issue. The Fifth Circuit has never addressed FDA authority (or lack thereof) over stem cell therapy.

Generally the FDA attempts to block and impede the use of adult stems cells as much as the FDA possibly can, and often beyond what Congress has authorized the FDA to do.

Analogous therapies

The Fifth Circuit found that "extracellular vesicle ("EV") [is a] product similar to stem cell therapy." Direct Biologics, L.L.C. v. McQueen, 63 F.4th 1015, 1017 (5th Cir. 2023) (deciding a trade secret-related issue.

In the 1990s, there was advocates of stem cell rescue procedures for breast cancer:

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The number of stem cell rescue procedures performed worldwide is increasing. By 1992, some 19,000 transplants had been performed, up from over 2,500 performed as of 1986. And the total number of transplants is expected to reach 251,000 by 1998 ....

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Smith v. Office of Civilian Health & Med. Program of the Uniformed Servs., 97 F.3d 950, 968 (7th Cir. 1996) (denying federal coverage for the procedure based an assertion that it was unproven).