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

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, a...

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Bibliographic Details
Published in:Cell stem cell 2018-06, Vol.22 (6), p.941-950.e6
Main Authors: Curtis, Erik, Martin, Joel R., Gabel, Brandon, Sidhu, Nikki, Rzesiewicz, Teresa K., Mandeville, Ross, Van Gorp, Sebastiaan, Leerink, Marjolein, Tadokoro, Takahiro, Marsala, Silvia, Jamieson, Catriona, Marsala, Martin, Ciacci, Joseph D.
Format: Article
Language:English
Subjects:
SCI
spinal cord injury
spinal surgery
stem cell therapy
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Summary: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. [Display omitted] •NSI-566 grafted injured spines in rats with near complete cavity-filling•The differentiation profile of grafted cells showed all three neural lineage cells•High-density human axonal sprouting was seen throughout the NSI-566 grafted region•NSI-566 transplanted in the spinal injury site of patients can be performed safely After promising results were seen in a pre-clinical human-spinal-cord-derived neural stem cell NSI-566 transplantation study for spinal cord injury in rats, a phase I clinical trial for NSI-566 transplantation was initiated in patients with complete thoracic SCI.
ISSN:1934-5909
1875-9777
DOI:10.1016/j.stem.2018.05.014