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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
Injection of 500mg of methylprednisolone immediately after admission before surgery.
Injection of the same volume of saline immediately after admission before surgery
Shanghai Changzheng Hospital
Shanghai, China
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.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment
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
Time frame: 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
Time frame: baseline, 3 months, 6 months and 12 months post-treatment
Residual urine test
Change in residual urine as measured by ultrasound test
Time frame: baseline, 3 months, 6 months and 12 months post-treatment
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