AXER-204 in Participants With Chronic Spinal Cord Injury

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion. Part 1 will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of AXER-204. Part 2 will evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 in comparison to placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ReNetX Bio, Inc.

Criteria

Key Inclusion Criteria:

1. Traumatic spinal cord injury that occurred ≥ 1 year ago

2. Cervical spinal cord injury with serious neurologic deficit as evidenced by 1) bilateral ISNCSCI UEMS between 4 and 36 points inclusive, and 2) bilateral GRASSP Prehension Ability score between 4 and 17 points inclusive

3. Confirmation by MRI of the following:

1. Chronic SCI (persistent spinal cord lesion)

2. For AIS grade of A without sensory or motor zone of partial preservation extending at least two levels caudal to the level of injury, no apparent transection of the cord

3. CSF space spanning the lesion

Key Exclusion Criteria:

1. Penetrating injury to the cord or spinal cord trauma caused by ballistic injury including gunshot that did not penetrate the spinal cord

2. History of stroke, cerebrovascular injury, or elevated intracranial pressure

3. Contraindications for lumbar puncture

4. Requiring mechanical ventilatory assistance of any type

5. Body mass index (BMI) ≥ 35 kg/m2 or body weight <50 kg

6. History of life threatening allergic or immune-mediated reaction to vaccines, or biologic drugs, at any time or any life threatening allergic or immune-mediated reaction within the past 12 months

7. Subjects fitted with an implanted pump or port for delivery of therapeutics to the CSF

8. Uncontrolled medical condition including but not limited to cardiovascular disease, sleep apnea, obstructive lung disease, severe neuropathic or severe chronic pain, severe autonomic dysreflexia

9. Participation in any other investigational drug or device trial within 30 days or within 5 half-lives of the investigational drug or any past participation in a SCI cellular therapy trial.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.