Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects

Biological/cell based
Standing/walking/mobility
Online since 2 November 2021, updated 928 days ago

About this trial

This trial is recruiting individuals with chronic complete thoracic (chest area) spinal cord injuries to test implantation of a biodegradable device containing nerve segments and growth molecules intended to boost nerve activity. The primary focus of the study is safety; motor improvements will also be measured by spinal cord motor nerve conduction. If included, participants will randomly undergo device implant surgery and walking training, or walking training only (control group). Follow-up will occur over 18 months. The control group will be offered surgical implantation of the device after completion of the study, if there are no major safety concerns.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T2 - T11
  • Severity (AIS)?
  • AIS-A
    Time since injury
    4 months - 10 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T2-T11
    Additionally, participants must
    have a BMI of less than 35.
    have a body height of less than 195cm (<6’4 feet).
    have a body weight of less than 125kg (<275 lbs).

    What’s involved

    Type

    Biological/cell based

    Details

    For the trial the participant will be randomly assigned either to undergo surgery to implant the device into the spinal cord and participate in study-specific walking training or assigned to only participate in study-specific walking training. Follow-up will be done over the following 18 months.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    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 Jun 2015
    • Organisation
    • BioArctic AB
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Jun 2015
    • Organisation
    • BioArctic AB

    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