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.