No stem cell therapy for peripheral neuropathy has FDA approval in the United States. The EU has not licensed any cell-based neuropathy product as a medicinal therapy. All treatments remain investigational or delivered under regulated clinical trial or compassionate access frameworks. Some countries (Spain, Portugal, Mexico) permit cell therapy for neuropathy under national medical access provisions. Regulatory recognition of efficacy is nascent; approval may follow positive large-scale trials expected 2026–2028.
Peripheral neuropathy encompasses diverse conditions—diabetic, idiopathic, chemotherapy-induced, ischaemic—characterised by progressive nerve fibre loss, demyelination, and sensorimotor dysfunction. Stem cell therapies exploit multiple pathways: placental mesenchymal stem cells (MSCs) secrete neurotrophic factors (NGF, GDNF, VEGF) that promote nerve regeneration and angiogenesis; neurogenic cells differentiate into functional neurons to replace damaged fibres; exosomes deliver growth factor cargo directly into affected peripheral tissues. The rationale combines neuroprotection (halting further degeneration), neuroregenerative repair (sprouting of surviving axons), and vascular restoration (improving ischaemic neuropathy). Forty-six registered trials investigate efficacy across neuropathy subtypes; eight actively recruit, indicating expanding clinical capacity and commercial interest.
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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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