Long-Term Clinical and Safety Outcomes from a Single-Site Phase I Study of Neural Stem Cell Transplantation for Chronic Thoracic Spinal Cord Injury

Abstract

We report the long-term results for a phase I study of neural stem cell transplantation for chronic spinal cord injury (SCI). 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 SCI in four subjects with T2-T12 SCI. Here, we report that all four subjects tolerated the stem cell implantation procedure well and two subjects had durable EMG quantifiable-evidence of neurological improvement as well as increased INSNSCI neurological motor and sensory scores at 5-years post-transplantation.

Note:
Registration Details: The trial was registered on ClinicalTrials.gov as NCT 01772810.

Funding Information: This work was supported by Sanford Stem Cell Clinical Center and the CIRM UC San Diego Alpha Stem Cell Clinic.

Declaration of Interests: The authors declare no competing interests.

Ethical Approval Statement: IRB approval was granted by UCSD Health Center, Human Research Protections Program (HRPP), 9452 Medical Center Drive, La Jolla, CA 92037.

Keywords: Spinal Cord Injury (SCI), stem cell therapy, spinal surgery