AXER-204 in Participants With Chronic Spinal Cord Injury
About this trial
This is a trial to test the safety, tolerability, and efficacy of different doses of a drug called AXER-204. The adult central nervous system maintains a set of proteins that limit growth and are bound to receptors on neurons. AXER-204 is a “decoy” or “trap” receptor that intercepts the blocking of these inhibitory proteins with the normal receptors. The presence of AXER-204 is designed to release the blockade on axon growth or axon regeneration after spinal cord injury (SCI). Animal experiments have shown that the AXER-204 human protein can remove this block and promote axonal regeneration and functional recovery after spinal cord injury. The study consists of two parts. If included in Part 1 of the trial, four groups of 6 participants will receive a single dose of AXER-204 (differing concentrations). If included in Part 2 of the trial, the participants will receive 1) repeated doses of AXER-204, or 2) repeated doses of an inactive drug (placebo control). The dose level and frequency will be dependent upon results from Part 1. The infusions are administered through a needle inserted between two vertebrae of the lower back (lumbar puncture). Final neurological examinations will be performed after 6 months.
Included participants
Traumatic
What’s involved
Type
Details
The study consists of two parts: If included in Part 1 of the trial, four groups of 6 participants will receive a single dose of AXER-204 (differing concentrations). If included in Part 2 of the trial, the participants will receive1) repeated doses of AXER-204, or 2) repeated doses of an inactive drug (placebo control). The dose level and frequency will be dependent upon results from Part 1. The infusions are administered through a needle inserted between two vertebrae of the lower back (lumbar puncture). Final neurological examinations will be performed after 6 months.
Potential benefits
Main benefits
General health
Additional benefits
Arm/hand function
Mental health
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- Recruitment
- Unknown
- Trial start date
- 16 Jul 2019
- Organisation
- ReNetX Bio, Inc.
- Recruitment
- Unknown
- Trial start date
- 16 Jul 2019
- Organisation
- ReNetX Bio, Inc.
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