Alofisel, an allogeneic MSC therapy, holds FDA approval for perianal Crohn's fistulae but not osteoarthritis. In the EU, one placental MSC product received ATMP approval for knee OA (conditional, with post-marketing surveillance), marking a regulatory milestone. Most knee OA cell therapies remain investigational or market-authorised under national compassionate frameworks. Approval pathways are evolving, but regulatory recognition of efficacy is not yet universal.
Knee osteoarthritis (OA) involves progressive degeneration of articular cartilage, underlying bone, and synovial tissue, culminating in pain, stiffness, and reduced mobility. Stem cell approaches exploit the regenerative capacity of placental mesenchymal stem cells (MSCs), which differentiate into chondrocytes (cartilage cells) and secrete anti-inflammatory cytokines. Chondrocytes derived from donor cartilage offer direct cartilage replacement. Exosomes from stem cells deliver growth factors into the joint space, potentially halting inflammatory cascades and stimulating endogenous repair. The therapeutic hypothesis is twofold: structural regeneration of damaged cartilage and immunological resolution of synovial inflammation driving pain. One hundred sixty-six registered trials globally reflect intense commercial and academic interest. Sixteen trials are actively recruiting, indicating rapid expansion of treatment capacity.
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由 StemCellAtlas 的编辑团队进行医学审查，与Dr Tymur Lukyanenko (Orthopaedic Traumatologist · 20+ yrs clinical, 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.
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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