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
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
Traumatic
What’s involved
Type
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
About this trial
Included participants
What’s involved
Potential benefits
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