Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI

Biological/cell based
General health
Online since 5 November 2021, updated 894 days ago

About this trial

This is a study to test the safety and effect of transplanting a type of stem cell (neural precursor) into the spinal cord of individuals with recent complete, cervical (neck area) spinal cord injury. The stem cells are derived from human embryos. The number of cells transplanted will be gradually increased as the study proceeds. Subsequent progress of individuals with transplants will be monitored by clinic visits; final testing will be performed after 1 year and 5 months.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C4 - C7
  • Severity (AIS)?
  • AIS-A
    Time since injury
    7 days - 60 days
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C4-C7
    Additionally, participants must
    NOT have penetrating injury, e.g. gunshot or knife wound
    NOT have history of malignant tumor
    NOT have immunodeficiency

    What’s involved

    Type

    Biological/cell based

    Details

    The first few individuals will receive surgery for the transplantation of “PSA-NCAM(+) NPC” injected into the “intrathecal” space around the spinal cord. If the first individuals at a given “dose” of cells do not develop any side effects, additional individuals will be included and receive the transplantation. The number of cells (dose) will be gradually increased as new individuals are included, as long as there are no adverse effects noted. Re-examination and testing will be performed at weeks 1, 2, 4, 8, 12, 24, 48, and 72 after surgery. This will include neurological testing, blood testing and Magnetic Resonance Imaging (MRI) of the spinal cord.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Pain

    Sensory function

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 23 Sep 2021
    • Organisation
    • S.Biomedics Co., Ltd.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 23 Sep 2021
    • Organisation
    • S.Biomedics Co., Ltd.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more