NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI

Biological/cell based
General health
Online since 14 March 2024, updated 98 days ago

About this trial

This trial is enrolling 22 individuals with chronic thoracic spinal cord injuries to test the safety and efficacy of an implanted scaffold combined with stem cells (Bone Marrow Mononuclear Cells; BMMC) into the injured spinal cord compared to surgical decompression, on neurological recovery. The scaffold (NeuroRegen™) is a man-made structure intended to mimic the natural tissue environment to support stem cell growth. If included, participants will be randomly assigned to receive either 1) the scaffold with stem cells derived from bone marrow or 2) decompression surgery. After surgery, all participants will receive rehabilitation, psychological and nutritional care. Final testing of neurological function will be performed after 24 months. *Note: detailed information about the stem cells, source of cells, need for immune suppression, etc. is not available on clinicaltrials.gov and will need to be provided by the investigator.

Included participants

Gender
All
Age
18 - 60 years
Injury level
T2 - T12
  • Severity (AIS)?
  • AIS-A
    Time since injury
    All
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T2-T12

    What’s involved

    Type

    Biological/cell based

    Details

    - participants will be randomly assigned to receive either 1) the scaffold with stem cell derived from bone marrow or 2) decompression surgery. - - The scaffold (NeuroRegen™) is a man-made structure intended to mimic the natural tissue environment to support stem cell growth. - After surgery, all participants will receive rehabilitation, psychological and nutritional care. - Final testing of neurological function will be performed after 24 months.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Bladder health/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
    • Unknown
    • Trial start date
    • 1 Jan 2016
    • Organisation
    • Chinese Academy of Sciences
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Jan 2016
    • Organisation
    • Chinese Academy of Sciences

    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