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Clinical Trial
. 2018 Jun 1;22(6):941-950.e6.
doi: 10.1016/j.stem.2018.05.014.

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

Erik Curtis  1 , Joel R Martin  1 , Brandon Gabel  1 , Nikki Sidhu  1 , Teresa K Rzesiewicz  2 , Ross Mandeville  3 , Sebastiaan Van Gorp  4 , Marjolein Leerink  4 , Takahiro Tadokoro  4 , Silvia Marsala  4 , Catriona Jamieson  2 , Martin Marsala  4 , Joseph D Ciacci  5
Affiliations
Free article
Clinical Trial

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

Erik Curtis et al. Cell Stem Cell. .
Free article

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.

Keywords: SCI; spinal cord injury; spinal surgery; stem cell therapy.

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