Darvadstrocel fistula healing typically requires 8–12 weeks to manifest and plateaus by 24 weeks. Sustained healing at 1 year is reported in 40–50%; relapse (recurrent drainage) occurs in 25–35%. Systemic MSC remission induction shows response onset at 4–8 weeks, peak effect at 12 weeks. Maintenance of remission without further therapy is observed in ~50% of responders at 12 months; others require re-induction at 6–12 month intervals. Long-term remission durability (≥3 years) without further cell therapy is incompletely characterised; most responders eventually require conventional maintenance therapy (5-ASA, biologics) to sustain remission.
Crohn's disease and ulcerative colitis (inflammatory bowel disease, IBD) involve chronic intestinal inflammation driven by aberrant immune responses to commensals and barrier dysfunction. Current therapies (aminosalicylates, corticosteroids, biologics) suppress inflammation but do not repair underlying mucosal defects or fully restore immune tolerance. Stem cell strategies exploit the immunoregulatory capacity of placental mesenchymal stem cells (MSCs), which secrete anti-inflammatory cytokines (IL-10, TGF-β) and promote regulatory T cell differentiation. MSCs also enhance barrier integrity by supporting tight-junction proteins and promoting mucosal healing. A particularly important development: darvadstrocel, an allogeneic MSC product, recently obtained European Union conditional approval for treatment of complex perianal Crohn's fistulae—marking the first regulatory recognition of cell therapy for IBD. Beyond this niche indication, systemic MSC therapy for induction remission and maintenance is investigational across 89 registered trials globally; thirteen actively recruit.
Am I a candidate? → · Crohn's & IBD: full overview → · Crohn's & IBD 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.
位于欧盟核心的 GMP 认证再生医学诊所——费用 3,000–8,000 欧元起，仅为美国或德国价格的一小部分。为来自 50 多个国家的国际患者提供个性化方案。
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