No stem-cell product for SCI holds FDA approval. Investigational trials in the USA operate under IND and expanded-access protocols; the Stem Cell Consortium and multiple university centres enrol eligible participants. European trials are registered with national competent authorities; regulatory pathways remain developmental. Patient eligibility criteria are rigorous (imaging confirmation, age/functional baseline requirements, extended informed consent).
Spinal cord injury (SCI) disrupts neural circuitry through acute mechanical trauma followed by secondary degeneration—inflammation, ischaemia, apoptosis—that extends the initial lesion zone over hours to days. Neurogenic stem cells and neural progenitor cells derived from umbilical cord or fetal sources can differentiate into oligodendrocytes (restoring myelin) and astrocytes (stabilising the lesion core), whilst also secreting neurotrophic factors (BDNF, NGF, NT-3) that promote axonal plasticity and regeneration. Placental mesenchymal stem cells provide complementary neuroprotection and angiogenesis. Sixty-nine registered trials and eight actively recruiting centres explore cell transplantation, often combined with rehabilitation, in both acute (<2 weeks) and chronic (>6 months) SCI populations.
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Revizuit medical de echipa editorială a StemCellAtlas cu Kiian Nadiia, MD, PhD (Paediatric Neurologist · Medical Director, CSM Clinic Network · 12+ yrs in Autism Spectrum Disorders) ale clinicii partenere Stem Plus (Sofia), în funcție de orientările ISSCR, FDA și EMA. Educational information, not medical advice; figures indicative.
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