Spinal Cord Injuries
Conditions
Keywords
spinal cord, spinal cord injury
Brief 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
Interventions
DRUGES135
ES135 will be administered via intrathecal
Sponsors
Eusol Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomized, Double-blind
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores | 48 weeks |
Countries
Taiwan
Outcome results
None listed