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Thread: A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic SCI

  1. #1

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

    Cell Stem Cell. 2018 Jun 1;22(6):941-950

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

    Curtis E1, Martin JR1, Gabel B1, Sidhu N1, Rzesiewicz TK2, Mandeville R3, Van Gorp S4, Leerink M4, Tadokoro T4, Marsala S4, Jamieson C2, Marsala M4, Ciacci JD5.


    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.

    https://www.ncbi.nlm.nih.gov/pubmed/29859175
    “As the cast of villains in SCI is vast and collaborative, so too must be the chorus of hero's that rise to meet them” Ramer et al 2005

  2. #2
    WOW! I didn't think we get this close in my lifetime! I know it's too early to tell whether this will pan out, it's still encouraging.

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