A First-in-Human, Phase I Study of Neural Stem Cell …

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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

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 T2T12 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 (1827months 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 earlysigns 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.

spinal cord injury

SCI

stem cell therapy

spinal surgery

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2018 Elsevier Inc.

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