AXER-204 in Participants With Chronic Spinal Cord Injury

Drug
General health
Online since 8 November 2021, updated 981 days ago

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

Gender
All
Age
18 - 65 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    have a spinal cord injury for at least 1 year.
    have a cervical spinal cord injury.
    have “serious” neurological deficits in upper extremity motor function (upper extremity motor score between 4-36 out of 50).

    What’s involved

    Type

    Drug

    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 and psychosocial factors

    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
    • Ended
    • Trial start date
    • 16 Jul 2019
    • Organisation
    • ReNetX Bio, Inc.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 16 Jul 2019
    • Organisation
    • ReNetX Bio, Inc.

    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