Autologous Bulbar Olfactory Ensheathing Cells and Nerve Grafts for Treatment of Patients With Spinal Cord Transection

Biological/cell based
Standing/walking/mobility
Online since 4 November 2021, updated 838 days ago

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

Gender
All
Age
16 - 65 years
Injury level
C5 - T10
  • Severity (AIS)?
  • AIS-A
    Time since injury
    1 month - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C5-T10
    Additionally, participants must
    NOT have implanted device, e.g. pacemaker
    be able to stay with an accompanying person for at least 3 years in Poland.
    apply via the walk-again-project.org recruitment website

    What’s involved

    Type

    Biological/cell based

    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
    • Unknown
    • Trial start date
    • 1 Mar 2016
    • Organisation
    • Nicholls Spinal Injury Foundation
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Mar 2016
    • Organisation
    • Nicholls Spinal Injury Foundation

    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