Long-term clinical and safety outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic thoracic spinal cord injury

• DOI: 10.1016/j.xcrm.2024.101841
• Publication Date: 2024-12-02T15:33:28Z
• Authors: Joel R. Martin; Daniel Cleary; Mickey E. Abraham; Michelle Mendoza; Betty Cabrera; Catriona Jamieson; Martin Marsala; Joseph D. Ciacci
• Keywords: Male; Adult; spinal surgery; 610; regenerative medicine; clinical trial; Middle Aged; spinal cord injury; Article; Treatment Outcome; Neural Stem Cells; SCI; stem cells; 616; Chronic Disease; Humans; Female; neurosurgery; neural stem cell therapy; Spinal Cord Injuries; Stem Cell Transplantation

We report the long-term results for a phase 1 study of neural stem cell transplantation for chronic spinal cord injury. The trial was registered on ClinicalTrials.gov as NCT01772810. The primary outcome of the trial was to test the feasibility and safety of human spinal cord-derived neural stem cell (NSI-566) transplantation for the treatment of chronic spinal cord injury in four subjects with thoracic two to thoracic twelve spinal cord injury. Here, we report that all four subjects tolerated the stem cell implantation procedure well, and two subjects had durable electromyography-quantifiable evidence of neurological improvement as well as increased neurological motor and sensory scores at five years post-transplantation.