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This experimental cell therapy consists of allogeneic human neural stem cells (hNSCs) derived from fetal tissue obtained from spontaneous abortions. Developed by Azienda Ospedaliera Santa Maria in Terni, Italy, in collaboration with the Fondazione Cellule Staminali and directed by Prof. Angelo Luigi Vescovi, the therapy is classified as an advanced therapy medicinal product (ATMP). The cells are expanded under Good Manufacturing Practice (GMP) conditions at the Cell Factory facility at Terni Hospital. The treatment is administered via direct intraspinal or intramedullar microinjection into the anterior horn of the spinal cord. The primary mechanism of action involves the potential replacement of degenerating motor neurons or the provision of neurotrophic support to slow the progression of Amyotrophic Lateral Sclerosis (ALS). A Phase I clinical trial (EudraCT 2009-014484-39) completed in 2015 demonstrated the safety and tolerability of the procedure in 18 patients, leading to subsequent Phase II investigations.
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