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RESET Trial: Two-Part Chronic SCI Study

ReNetX Safety, Efficacy and Tolerability of AXER-204 for Chronic SCI

AXER-204 was found to help promote nerve growth and possible neurological recovery in animal laboratory studies using rats and monkeys. While a single dose is not expected to promote neurological recovery in humans, this study will confirm its safety and tolerability. A follow up study will test the potential effects of repeated doses.

This is the first clinical study to date being conducted in humans with AXER-204.

Part 1:

Part 1 of the trial is a multicenter, open-label, single ascending dose study in participants with chronic cervical spinal cord injury. The purpose of Part 1 is to determine if a single dose of an investigational drug, AXER-204, can be safely injected into the spinal canal and tolerated by people with chronic spinal cord injury (SCI). Four cohorts of 6 participants each are planned, with participants within each cohort expected to receive the same dose of AXER-204.

Part 1 concluded in Summer of 2020.

Part 2:

Part 2 is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in chronic cervical spinal cord injury participants. The purpose of Part 2 is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 compared to placebo. Up to 42 participants will be randomized (ratio 1:1) to receive repeated doses of AXER-204 or placebo (a phosphate buffered saline formulation). The dose level and dose frequency will be dependent upon outcomes from Part 1.

Part 2 participants are currently in long term follow up; recruitment is closed.

Who qualifies for this study?

  • To participate in this study, you must meet the following criteria:
    • 18 – 65 years old
    • Traumatic SCI that occurred greater than 1 year ago
    • Cervical SCI with weakness in the arms and/or hands
    • In excellent overall health
  • If any of the following apply to you, you are not eligible to participate:
    • History of a stroke, brain injury, or any other chronic medical condition
    • Implanted baclofen or pain pump
    • Require any assistance to breathe (i.e. mechanical ventilation)
    • Recent medication changes
    • Penetrating Injury (i.e. Gunshot/stabbing)