TNFα Monoclonal Antibody for Acute Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of subcutaneous injection of TNFα monoclonal antibody cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). The pathological process of spinal cord injury include primary injury (initial traumatic insult) and a progressive secondary injury cascade characterized by ischemia, proapoptotic signaling, peripheral inflammatory cell infiltration and the release of proinflammatory cytokines. Secondary injury plays a key role in the loss of spinal cord function after trauma. So early treatment to prevent the secondary injury is the key to improve prognosis. TNFα monoclonal antibody is a TNF-α inhibitor that could control inflammatory response, and now widely used in the treatment of Ankylosing spondylitis, Rheumatoid arthritis and other autoimmune diseases. In this study, the investigators will treat patients with acute spinal cord injury with TNFα monoclonal antibody and compare with the control group.

Official Title
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Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Drug: TNFα Monoclonal Antibody
* Drug: Methylprednisolone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 60 years Traumatic spinal cord injury ASIA Impairment Scale A-D The injury must be within two weeks Patients submitted written informed consent Exclusion Criteria: Traumatic spinal cord injury with brain injury or peripheral nerve injury Patients with severe multiple injuries and unstable vital signs Non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc. Patients with central spinal cord injury Patients with a completely transected spinal cord Patients with fever or acute infection Ongoing infectious disease, such as tuberculosis, HIV, hepatitis, syphilis, etc. Patients with malignant tumour Patients with neurodegenerative diseases, or any neuropathies Patients with ankylosing spondylitis Patients with a previous history of spinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNFα monoclonal antibody group<br>Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery. | Drug: TNFα Monoclonal Antibody<br>* Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.<br>|
| Active Comparator: Methylprednisolone group<br>Injection of 500mg of methylprednisolone immediately after admission before surgery. | Drug: Methylprednisolone<br>* Injection of 500mg of methylprednisolone immediately after admission before surgery.<br>|
| Placebo Comparator: Control group<br>Injection of the same volume of saline immediately after admission before surgery. | Drug: Saline<br>* Injection of the same volume of saline immediately after admission before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Spinal Injury Association Impairment Scale(ASIA) | Change in sensory and motor function as measured by the American Spinal Injury Association Impairment Scale (ASIA). The scale ranked from A to E, A indicates the the most severe spinal cord injury and E indicates no neurological deficit. | baseline, 1 month, 3 months, 6 months and 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Any abnormal signs, symptoms, findings, or diseases that emerge or worsen relative to baseline in 1 month posttreatment will be recorded as adverse event | 1 month post-treatment | 
| Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test | Change in sensory and motor function will be measured by SSEP and MED test | baseline, 3 months, 6 months and 12 months post-treatment | 
| Residual urine test | Change in residual urine as measured by ultrasound test | baseline, 3 months, 6 months and 12 months post-treatment |