TNFα Monoclonal Antibody for Acute Spinal Cord Injury

Drug
General health
Online since 3 April 2022, updated 835 days ago

About this trial

This is a trial recruiting individuals with acute (less than two weeks) spinal cord injuries to test the effect of an anti-inflammatory treatment. While a spinal cord injury produces immediate damage, there are also delayed, secondary negative effects such as those caused by inflammation. The natural molecule TNFα triggers inflammatory responses. TNFα can be blocked, however, using a specific antibody. This study will investigate the effects of a TNFα antibody injected directly under the skin surface. If included, participants will be randomly assigned to one of three study groups: a) receiving an injection of the TNFα antibody; b) receiving an injection of a conventional anti-inflammatory drug (methylprednisolone); or c) receiving a placebo injection (no therapeutic effect). The injection will be performed after admission to the hospital and before any surgery to stabilize the spine. Final testing, including changes in sensory and motor function, will be performed after 12 months.

Included participants

Gender
All
Age
18 - 60 years
Injury level
Level not specified
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 2 weeks
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Drug

    Details

    - Injection of a medication under the skin surface - Participate in outcome assessments before the injection and then 1 month, 3 months, 6 months, and 12 months after the injection. Outcome assessments include tests of skin and muscle function, bladder ultrasounds, and documentation of adverse events.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Sensory function

    Standing/walking/mobility

    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 Sep 2022
    • Organisation
    • Shanghai Changzheng Hospital
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Sep 2022
    • Organisation
    • Shanghai Changzheng Hospital

    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