The Safety of ahSC in Chronic SCI With Rehabilitation

Biological/cell based
Standing/walking/mobility
Online since 10 July 2024, updated 5 days ago

About this trial

This trial is recruiting individuals with spinal cord injuries to study the safety and effect of cell transplantation as a treatment. Schwann cells harvested from the sural nerve (located in the lower leg) of each participant will be transplanted into the center of the participant's spinal cord injury. Researchers want to see if these cells promote functional recovery by repairing myelin (insulation) on spinal cord nerves. Potential recovery will be enhanced by fitness and rehabilitation activities before and after transplantation. If selected, participants will undergo surgery to collect the cells and place them into the spinal cord. Enrollment will target 2 participant groups, thoracic level and cervical level. Safety and functional assessments will be done after transplantation at weeks 1 and 2 and months 2 and 6.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C5 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C5-T12
    Additionally, participants must
    be able to undergo an MRI.
    have a Body Mass Index (BMI) less than 35

    What’s involved

    Type

    Biological/cell based

    Details

    At the University of Miami (prior and post surgery), participants will receive fitness conditioning and rehabilitation in order to maintain health and promote neuronal activity and potential neuroplasticity within the central nervous system. Monitoring throughout 6 months post-surgery.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    Bladder health/function

    Bowel health

    General health

    Pain

    Sensory function

    Sexual health

    Spasticity

    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
    • Ended
    • Trial start date
    • 1 Jan 2015
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Jan 2015
    • Organisation
    • University of Miami

    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