Question

针对 狼疮(SLE) 的干细胞疗法获得了 FDA 批准吗?

No stem-cell therapy for lupus holds FDA approval. Clinical trials in the USA operate under IND (Investigational New Drug) protocols; recruitment is ongoing at university hospital centres. International trials in Europe and Asia are registering participants for phase II expansion. Patients must understand this remains experimental, with efficacy and optimal dosing not yet established by regulatory consensus.

How stem cells are studied for Lupus (SLE)

Lupus (systemic lupus erythematosus, SLE) is an autoimmune disease in which the body's immune system mistakenly attacks its own tissues, particularly affecting joints, skin, kidneys, and the nervous system. The condition arises when B cells and T cells lose tolerance to self-antigens, producing damaging antibodies and inflammatory cytokines. Placental mesenchymal stem cells show promise because they release immunomodulatory factors—interleukins, soluble HLA-G, and exosomes containing regulatory microRNAs—that rebalance Th17 and regulatory T-cell populations. Early-stage clinical research (47 registered trials, 6 currently recruiting) suggests this approach may reduce disease activity scores and improve organ function in selected patients, though long-term remission rates remain under investigation.

我是候选人吗? → · Lupus (SLE): full overview → · 狼疮(SLE)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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