A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eusol Biotech Co., Ltd.

Criteria

Inclusion Criteria:

1. Subjects of either sex and 15-65 years of age.

2. Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.

3. Subjects have adequate heart, lung, kidney and liver function.

4. Subjects are able to give voluntary and dated informed consent prior to enrollment.

Exclusion Criteria

1. Penetration SCI

2. Brain damage or multiple injuries

3. History of congenital or acquired abnormalities in the spinal cavity

4. History of congenital or acquired immunodeficiency disorders

5. History of malignancies or positive results

6. Current serious/uncontrollable infections or others serious diseases

7. Pregnant or lactating women

8. Allergy to ES135 or any of its excipients

9. Unable to obtain informed consent from subject