Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury

Biological/cell based
Standing/walking/mobility
Online since 2 November 2021, updated 897 days ago

About this trial

This is a clinical trial enrolling individuals with chronic complete spinal cord injuries in the thoracic (chest) and lumbar (lower back) areas to test the safety and effect of a stem cell injection. This study uses cells collected from each participant’s own bone marrow. If included in the study, participants will be randomly assigned to one of two groups receiving: 1) stem cells (treatment group), or 2) no stem cells (control group). Participants in the treatment group will receive two injections of stem cells over 3 months. Both treatment and control groups will be assessed for safety, functional improvement and nerve pain over 12 months.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T1 - L2
  • Severity (AIS)?
  • AIS-A
    Time since injury
    12 months - 65 years
  • Injury type
  • Ischemia

    Healthy volunteers
    No
    T1-L2
    Additionally, participants must
    NOT have diabetes mellitus type 1 or 2
    NOT have SCI due to sharp object or firearm
    NOT have other metallic implant that would affect MRI

    What’s involved

    Type

    Biological/cell based

    Details

    Two injections to transplant the mesenchymal stem cells Assessment of outcome measures for 12 months after transplantation

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bone health

    General health

    Mental health and psychosocial factors

    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
    • Unknown
    • Trial start date
    • 1 Dec 2019
    • Organisation
    • Hospital Sao Rafael
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Dec 2019
    • Organisation
    • Hospital Sao Rafael

    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