Question

针对 溃疡性结肠炎 的干细胞疗法获得了 FDA 批准吗?

No MSC or stem cell therapy is FDA-approved for ulcerative colitis. An allogeneic MSC product (darvadstrocel) is approved in the EU for complex perianal Crohn's fistulae, a related but distinct IBD indication. This precedent demonstrates regulatory feasibility for MSCs in IBD but does not extend to UC without separate clinical evidence. Clinics offering UC-targeted stem cell treatments operate outside formal regulatory pathways in most jurisdictions.

How stem cells are studied for Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory bowel disease affecting the colon and rectum, characterised by bloody diarrhoea, urgency, abdominal pain, and systemic complications including anaemia and extraintestinal manifestations. Modern management combines 5-aminosalicylate agents, immunosuppression, and biologic therapies; however, a significant proportion of patients experience relapsing disease or intolerance to standard drugs. Mesenchymal stem cell research in UC explores whether cell-derived immunomodulatory factors might suppress mucosal inflammation and promote tissue healing. Related approved therapies (such as an MSC product indicated for perianal Crohn's fistulae) provide mechanistic precedent, though this distinct indication remains investigational in UC.

我是候选人吗? → · Ulcerative Colitis: full overview → · 溃疡性结肠炎成本 → · Cost →

由 StemCellAtlas 的编辑团队进行医学审查,与Dr Polina Krasenova (Haematologist · Clinical Haematology & Integrative Oncology · 15+ yrs cell therapy) 合作诊所 Stem Plus(索菲亚)的,根据 ISSCR、FDA 和 EMA 指南。 Educational information, not medical advice; figures indicative.

欧洲品质的细胞疗法,没有欧洲的价格。

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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