Is stem cell therapy for Ulcerative Colitis FDA-approved?
No MSC or stem cell therapy is FDA-approved for ulcerative colitis. Darvadstrocel formerly had EU authorisation for complex perianal Crohn's fistulae, a related but distinct indication, but the EU marketing authorisation was withdrawn in December 2024. It does not establish approval or efficacy for ulcerative colitis.
How stem cells are studied for Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease affecting the colon and rectum. Mesenchymal stem cell research in UC explores immunomodulatory and tissue-repair mechanisms, but this remains investigational. Darvadstrocel, an MSC product formerly authorised in the EU for complex perianal Crohn's fistulae, had its marketing authorisation withdrawn in December 2024; that former indication did not establish efficacy for ulcerative colitis.
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