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

Cell Rep Med. 2024 Dec 17;5(12):101841. doi: 10.1016/j.xcrm.2024.101841. Epub 2024 Dec 2.

Abstract

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.

Keywords: SCI; clinical trial; neural stem cell therapy; neurosurgery; regenerative medicine; spinal cord injury; spinal surgery; stem cells.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Chronic Disease
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neural Stem Cells* / transplantation
  • Spinal Cord Injuries* / therapy
  • Stem Cell Transplantation* / adverse effects
  • Stem Cell Transplantation* / methods
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01772810