Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training

Biological/cell based
Standing/walking/mobility
Online since 4 November 2021, updated 844 days ago

About this trial

This trial is recruiting individuals with chronic, complete spinal cord injuries to assess the effect of transplanting a type of stem cell (cells that can turn into different cell types). This study uses cells from the umbilical cord (umbilical cord blood mononuclear stem cells; UCBMSC). The cells will be surgically transplanted into the spinal cord. After the transplant, the study also adds lithium carbonate (Li2CO3) taken by mouth for 6 weeks, followed by intensive stepping (locomotor) training for 3-6 months (up to 6 hours per day, 6 days per week). If included in the study, participants will be randomly assigned to one of the three study groups: walking training only; walking training + UCBMSC transplantation + placebo; or walking training + UCBMSC transplantation + lithium carbonate. All participants will receive 3-6 months of intensive locomotor training and will be assessed for walking ability, other activities of daily living, and overall sensory and motor function over 48 weeks.

Included participants

Gender
All
Age
18 - 60 years
Injury level
C5 - T11
  • Severity (AIS)?
  • AIS-A
    Time since injury
    1 year - 60 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C5-T11
    Additionally, participants must
    be able stand at least 1 hour/day using a standing frame, tilt table, or equivalent device.
    NOT have received lithium treatment in past month
    NOT take medication that may interfere with lithium clearance

    What’s involved

    Type

    Biological/cell based

    Details

    Surgery for the transplantation of the stem cells into the spinal cord 6 weeks of lithium carbonate intake 3-6 months intensive locomotor training: Up to 6 hours a day, 6 days a week

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Pain

    Sensory function

    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
    • 22 Feb 2022
    • Organisation
    • StemCyte International, Ltd.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Feb 2022
    • Organisation
    • StemCyte International, 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