No FDA-approved stem-cell therapy exists for MS. Several products are in Phase 2; none has completed pivotal Phase 3 trials. Established MS drugs (interferons, monoclonal antibodies, oral agents) are FDA-approved and demonstrate disease modification — stem cells are investigational by comparison. 'FDA-approved' stem-cell MS claims are false.
Multiple sclerosis arises from immune-mediated attack on myelin and oligodendrocytes in the central nervous system, causing demyelination and axonal loss. Stem-cell strategies target both immune dysregulation and repair: placental mesenchymal stem cells are studied for their capacity to calm autoreactive immune cells and secrete neuroprotective factors, while neurogenic cells are explored for remyelination and axonal support. Preclinical work suggests stem cells migrate toward lesions and release anti-inflammatory mediators. Trials have enrolled relapsing-remitting and progressive forms, but the mechanism of any benefit is incompletely characterised, and no approach yet reverses established disability or halts long-term progression in humans.
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Medically reviewed by StemCellAtlas’s editorial team with Kiian Nadiia, MD, PhD (Paediatric Neurologist · Medical Director, CSM Clinic Network · 12+ yrs in Autism Spectrum Disorders) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.
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