Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury

Biological/cell based
General health
Online since 28 August 2023, updated 23 days ago

About this trial

This trial is enrolling 40 individuals with subacute (3-6 months post injury), complete thoracic or lumbar spinal cord injuries (paraplegia) to test the safety and effectiveness of transplanted stem cells. The stem cells (autologous) are harvested and processed from each participant’s bone marrow, limiting an immune rejection response. If included, participants will either undergo: 1) spinal surgery to expose the spinal cord, followed by the injection of the stem cells into the injured spinal cord and surrounding spinal fluid; or 2) placebo injection under the skin. Both groups will receive two injections, separated by 90 days. Final testing of neurological function will be performed after one year.

Included participants

Gender
All
Age
≥ 18 years
Injury level
T1 - L5
  • Severity (AIS)?
  • AIS-A
    Time since injury
    3 months - 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T1-L5
    Additionally, participants must
    NOT have metal implants (e.g., pacemaker)

    What’s involved

    Type

    Biological/cell based

    Details

    - Participants will either undergo 1) spinal surgery to expose the spinal cord, followed by the injection of the stem cells into the injured spinal cord and surrounding spinal fluid or 2) placebo injection under the skin. - Both groups will receive 2 injections, separated by 90 days. - Final testing of neurological function will be performed after 1 year.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health

    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 soon
    • Trial start date
    • 1 Apr 2023
    • Organisation
    • SENAI CIMATEC
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Apr 2023
    • Organisation
    • SENAI CIMATEC

    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