Are There Any FDA-Approved Stem Cell Therapies? Understanding the Regulated Landscape
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3 min read
As of 2025, the U.S. Food and Drug Administration (FDA) has approved a limited number of stem cell therapies, primarily those using blood-forming hematopoietic progenitor cells from umbilical cord blood for specific blood and immune disorders. The vast majority of stem cell products marketed by unproven clinics are not approved by the FDA and carry significant risks.
