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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04988425
Study type Interventional
Source Shanghai Changzheng Hospital
Contact Xuhua Lu, M.D.
Phone +862181885793
Email xuhualu@hotmail.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 1, 2022
Completion date August 30, 2023

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