Is stem cell therapy for Psoriasis FDA-approved?
No stem-cell product is FDA-approved for psoriasis. An IND-authorised study or registry listing is not product approval. In Europe, a trial authorisation is distinct from EMA marketing authorisation. Patients should verify the exact product, sponsor, registry identifier, competent authority and ethics approval rather than rely on general ATMP or regenerative-medicine language.
How stem cells are studied for Psoriasis
Psoriasis is a chronic immune-mediated inflammatory disease characterised by dysregulated T-cell signalling and keratinocyte proliferation. Genetic susceptibility and environmental triggers both contribute. Mesenchymal stromal cells (MSCs) and extracellular vesicles are being studied for proposed immunomodulatory effects involving pathways such as IL-17 and regulatory T-cell signalling. Those mechanisms have not established comparative clinical benefit against approved psoriasis treatments. The registry table on this page lists relevant studies and their current recruitment status.
Am I a candidate? → · Psoriasis: full overview → · Psoriasis 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.