Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care

Surgery
General health
Online since 4 November 2021, updated 1127 days ago

About this trial

This trial is recruiting individuals with acute, complete, thoracic (chest area) spinal cord injuries to test the safety and effect of an implanted scaffold. The scaffold is surgically implanted within seven days of injury in the center of the spinal cord injury area during spine stabilization surgery (a standard of care treatment). Safety, clinical and functional changes will be assessed after implantation. The scaffold implant will be resorbed by the participant’s body within 4-8 weeks. If selected for the trial, participants will be randomly assigned to either receive the scaffold as a part of standard surgical treatment, or be a part of the control group that does NOT receive the scaffold implantation as part of standard surgical treatment. Participants will be blinded — they will not know if they received the scaffold or not. Researchers will compare functional changes between the scaffold group and the controls.

Included participants

Gender
All
Age
16 - 70 years
Injury level
T2 - T12
  • Severity (AIS)?
  • AIS-A
    Time since injury
    ≤ 7 days
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T2-T12
    Additionally, participants must
    have a non-penetrating SCI (contusion or crush type of SCI).

    What’s involved

    Type

    Surgery

    Details

    As part of the standard of care surgery after a SCI, the participant will either have the scaffold implanted into the center of the spinal cord zone of injury or he will be a participant in the control group (no scaffold implant).

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Bladder health/function

    Bowel health

    Sexual health

    Standing/walking/mobility

    Mechanism of action

    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
    • 21 May 2019
    • Organisation
    • InVivo Therapeutics
    • Trial recruitment status
    • Ended
    • Trial start date
    • 21 May 2019
    • Organisation
    • InVivo Therapeutics

    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