Autologous Bulbar Olfactory Ensheathing Cells and Nerve Grafts for Treatment of Patients With Spinal Cord Transection
About this trial
This trial is recruiting individuals with complete spinal cord transection injuries (fully severed cord, e.g. from knife wound) to test the use of nerve cells collected from each participant (autologous) to rebuild their damaged cord. The cells are called olfactory ensheathing cells (OECs) and olfactory nerve fibroblasts (ONFs). The study will investigate the safety and ability of OECs and ONFs to build a nerve bridge across the injury site in order to regain some feeling and voluntary movement. On the basis of single case report, this method has been shown to enable some sensory and motor function recovery. If selected for the study, participants will be screened for natural recovery during an 8-month rehabilitation phase. If no signs of improvement appear, the participant will receive two surgeries (one for cell implantation on a scaffold, one for bridging the area of damage with peripheral nerve segments), followed by at least two years of rehabilitation.
Included participants
Traumatic
What’s involved
Type
Details
Screening phase of 8-months of neurorehabilitation If there is no electrophysiological and clinical signs of recovery, the participant will enter the surgical part of the study First surgery to get the OECs on ONFs from up and inside your nose (olfactory bulb) to produce a “Glial Neuropatch” Second surgery to implant “Glial Neuropatch” along with part of a nerve taken from your lower leg to bridge the injury gap of your spinal cord. 2 years of neurorehabilitation after the surgeries
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
Arm/hand function
Bladder health
Bone health
General health
Mental health
Sensory function
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
- Recruiting
- Trial start date
- 1 Mar 2016
- Organisation
- Nicholls Spinal Injury Foundation
- Trial recruitment status
- Recruiting
- Trial start date
- 1 Mar 2016
- Organisation
- Nicholls Spinal Injury Foundation
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