RESET Trial: Chronic SCI Study

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

The purpose of this study 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).

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.

What happens if I choose to participate?

  • Participants will have 5 lumbar punctures performed during this study. One lumbar puncture will be for administration of the drug and the others will be research testing.
  • If you are eligible, you will be in this study for approximately 8 weeks, including a 4-day, 3-night inpatient stay.

Do I have to stay in the hospital?

  • After receiving an injection of the study drug, participants must remain in Shepherd’s inpatient unit for monitoring.

How often do I have to come to Shepherd?

  • After staying at Shepherd for 4-days and 3-nights, participants will return to Shepherd 8 days, 15 days, and 29 days after the initial injection for additional testing and follow-up.
  • Participants will be provided a small amount of compensation for time and travel.

Who qualifies for this study?

  • To participate in this study, you must meet the following criteria:
    • 18 – 65 years old
    • Traumatic SCI that occurred >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)

If you feel like you may qualify and would be interested in learning more, please complete the following intake form. You will be contacted by study staff if you meet criteria.

ReNetX Chronic SCI Study Intake Form

Personal Information

MM/DD/YYYY

Study-Related Information

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i.e. auto accident, fall, etc.

Do you have any other significant medical issues or other diagnoses that we should be aware of, such as high blood pressure, diabetes, cardiac pacemaker, stroke, cardiac disease, skin breakdown, etc.?