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| Name | Class |
|---|---|
| The First People's Hospital of Kunshan | OTHER |
| Kunshan Hospital of Traditional Chinese Medicine | OTHER |
| 904th Hospital of the Joint Logistics Support Force of the PLA | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNFα monoclonal antibody group | Experimental | Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery. |
|
| Methylprednisolone group | Active Comparator | Injection of 500mg of methylprednisolone immediately after admission before surgery. |
|
| Control group | Placebo Comparator | Injection of the same volume of saline immediately after admission before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNFα Monoclonal Antibody | Drug | Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuhua Lu, M.D. | Contact | +862181885793 | xuhualu@hotmail.com | |
| Bangke Zhang, M.D. | Contact | +8618301783716 | zbk12345@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuhua Lu, M.D. | Shanghai Changzheng Hospotal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Shanghai | 200003 | China |
IPD will be available through email when requested
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| The Sixth People's Hospital of Nantong, China |
| UNKNOWN |
| Zhejiang Provincial Hospital of TCM | OTHER |
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Random grouping
| Methylprednisolone | Drug | Injection of 500mg of methylprednisolone immediately after admission before surgery. |
|
| Saline | Drug | Injection of the same volume of saline immediately after admission before surgery |
|
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 |
| D014947 | Wounds and Injuries |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |