A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury.

Abstract

We tested the feasibility and safety of human-spinal-cord-derived neural stem cell (NSI-566) transplantation for the treatment of chronic spinal cord injury (SCI). In this clinical trial, four subjects with T2-T12 SCI received treatment consisting of removal of spinal instrumentation, laminectomy, and durotomy, followed by six midline bilateral stereotactic injections of NSI-566 cells. All subjects tolerated the procedure well and there have been no serious adverse events to date (18-27 months post-grafting). In two subjects, one to two levels of neurological improvement were detected using ISNCSCI motor and sensory scores. Our results support the safety of NSI-566 transplantation into the SCI site and early signs of potential efficacy in three of the subjects warrant further exploration of NSI-566 cells in dose escalation studies. Despite these encouraging secondary data, we emphasize that this safety trial lacks statistical power or a control group needed to evaluate functional changes resulting from cell grafting.

• Authors: Erik Curtis, Joel R Martin, Brandon Gabel, Nikki Sidhu, Teresa K Rzesiewicz, Ross Mandeville, Sebastiaan Van Gorp, Marjolein Leerink, Takahiro Tadokoro, Silvia Marsala, Catriona Jamieson, Martin Marsala, Joseph D Ciacci
• Journal: Cell stem cell (Cell Stem Cell) Vol. 22 Issue 6 Pg. 941-950.e6 (Jun 01 2018) ISSN: 1875-9777 [Electronic] United States
• PMID: 29859175 (Publication Type: Case Reports, Clinical Trial, Phase I, Journal Article)
• Copyright: Copyright © 2018. Published by Elsevier Inc.

Topics

• Adult
• Animals
• Cell Line
• Chronic Disease
• Female
• Humans
• Male
• Neural Stem Cells (cytology, transplantation)
• Rats
• Rats, Nude
• Spinal Cord Injuries (pathology, surgery, therapy)
• Stem Cell Transplantation (adverse effects)
• Young Adult