Question

Is stem cell therapy for Crohn's & IBD FDA-approved?

Do not describe Alofisel as currently EU-authorised: its EU marketing authorisation was withdrawn on 13 December 2024. Verify any exact product and indication with the relevant regulator; trial registration or hospital manufacture is not marketing authorisation.

Medical review statusPending clinical sign-offLast evidence update: 2026-08-05Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

How stem cells are studied for Crohn's & IBD

Crohn's disease and other inflammatory bowel diseases (IBD) have different patterns, complications and established medical and surgical treatments. Cell research includes systemic immune approaches and local treatment of selected fistulas. Results from one local product and indication cannot validate intravenous MSCs for luminal disease, ulcerative colitis or general gut healing.

Am I a candidate? → · Crohn's & IBD: full overview → · Crohn's & IBD cost → · Cost →

Evidence checked against ISSCR, FDA and EMA guidance. See our editorial standards. This is information, not medical advice. Educational information, not medical advice; figures indicative.

Sources & further reading

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Compare cell-therapy evidence, registered studies and published price observations.

StemCellAtlas is a source-first research and cost-planning guide. It separates registry and regulator evidence from heterogeneous commercial observations.

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