Stem cell / cellular rejuvenation

What it is

Stem cell rejuvenation, as clinics sell it, most often means autologous mesenchymal stem or stromal cells drawn from a patient's own fat or bone marrow, processed and reinfused, marketed to regenerate tissue and slow aging. The FDA has approved no such product for any aging indication; the only approved stem cell products are umbilical cord blood cells for blood-formation disorders. Its enforcement discretion period ended May 31, 2021, and in September 2024 the Ninth Circuit ruled that a large clinic network's adipose cell product is a drug requiring approval. Availability elsewhere is regulatory, not evidentiary. Japan's Act on the Safety of Regenerative Medicine has certified committees vet a provision plan for safety rather than efficacy, letting clinics sell autologous therapy as self-pay care with no product approval, and South Korea's 2024 amendment created a comparable route.