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.
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.
Am I a candidate? → · Lupus (SLE): full overview → · Lupus (SLE) 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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