Spinal Cord Injuries
Conditions
Brief summary
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.
Interventions
DRUGTNFα Monoclonal Antibody
Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
DRUGMethylprednisolone
Injection of 500mg of methylprednisolone immediately after admission before surgery.
DRUGSaline
Injection of the same volume of saline immediately after admission before surgery
Sponsors
The First People's Hospital of Kunshan
Traditional Chinese Medicine Hospital of Kunshan, China
904th Hospital of the Joint Logistics Support Force of the PLA
The Sixth People's Hospital of Nantong, China
Zhejiang Provincial Hospital of TCM
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Random grouping
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Spinal Injury Association Impairment Scale(ASIA) | baseline, 1 month, 3 months, 6 months and 12 months post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 1 month post-treatment | Any abnormal signs, symptoms, findings, or diseases that emerge or worsen relative to baseline in 1 month posttreatment will be recorded as adverse event |
| Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test | baseline, 3 months, 6 months and 12 months post-treatment | Change in sensory and motor function will be measured by SSEP and MED test |
| Residual urine test | baseline, 3 months, 6 months and 12 months post-treatment | Change in residual urine as measured by ultrasound test |
Countries
China
Contacts
Primary ContactXuhua Lu, M.D.
Backup ContactBangke Zhang, M.D.
Outcome results
None listed