TNFα Monoclonal Antibody for Acute Spinal Cord Injury
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
Traumatic
What’s involved
Type
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
Arm/hand function
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
- Recruiting soon
- Trial start date
- 1 Sep 2022
- Organisation
- Shanghai Changzheng Hospital
- Trial recruitment status
- Recruiting soon
- Trial start date
- 1 Sep 2022
- Organisation
- Shanghai Changzheng Hospital
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