Question

Is stem cell therapy for Psoriasis FDA-approved?

No stem-cell product for psoriasis holds FDA approval. Clinical trials are investigational; no IND protocols are currently open in the USA at major dermatology centres. European trials are registered but recruitment is limited. Regulatory appetite for PSC therapies in dermatology appears modest compared to systemic autoimmune diseases, likely due to effective conventional and biological alternatives.

How stem cells are studied for Psoriasis

Psoriasis is a chronic autoimmune inflammatory skin disease characterised by dysregulated T-cell responses (excessive Th17 and Th1 differentiation), keratinocyte hyperproliferation, and abnormal epidermal-dermal architecture. Genetic susceptibility (HLA-Cw6 and multiple polygenic loci) interacts with environmental triggers (stress, infection, trauma) to initiate disease. Placental mesenchymal stem cells and their exosomes modulate psoriasis through multiple mechanisms: IL-17 suppression, regulatory T-cell induction (enhanced Foxp3+ Treg populations), keratinocyte proliferation restraint via TGF-β signalling, and direct anti-inflammatory cytokine secretion (IL-10, TGF-β). Eleven registered clinical trials and zero actively recruiting protocols suggest mature but limited clinical translation, with focus on moderate-to-severe, refractory disease unsuitable for conventional topical or systemic approaches.

Am I a candidate? → · Psoriasis: full overview → · Psoriasis cost → · Cost →

Medically reviewed by StemCellAtlas’s editorial team with Dr Polina Krasenova (Haematologist · Clinical Haematology & Integrative Oncology · 15+ yrs cell therapy) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.

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