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

Biological/cell based
General health
Online since 10 July 2024, updated 163 days ago

About this trial

This trial is recruiting individuals with chronic, complete cervical (neck area) spinal cord injuries to test the safety and effect of a stem cell implantation into the spinal cord. The stem cells are harvested from each participant’s bone-marrow, thus minimizing an immune rejection response to the implanted cells. If selected, participants will undergo a procedure to gather cells from their bone marrow for processing into treatment cells. This will be followed by spinal surgery for the implantation of the cells into the spinal cord. This study is mainly about safety, but changes in motor and sensory function will be measured.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C5 - C7
  • Severity (AIS)?
  • AIS-A
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C5-C7
    Additionally, participants must
    have a spinal cord injury for at least 12 months
    have a neurological level of injury between C5 and C7
    have the following ASIA impairment scale (AIS) grade:

    What’s involved

    Type

    Biological/cell based

    Details

    Undergo a procedure to harvest bone marrow cells for processing into the interventional stem cell product Undergo spinal surgery to implant the stem cell interventional product into the spinal cord Have assessment of outcome measures 12 months after surgery

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health and psychosocial factors

    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
    • Unknown
    • Trial start date
    • 6 Sep 2017
    • Organisation
    • Hospital Sao Rafael
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 6 Sep 2017
    • 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