NCT04988425

TNFα Monoclonal Antibody for Acute Spinal Cord Injury

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DRUG	TNFα Monoclonal Antibody	Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
DRUG	Methylprednisolone	Injection of 500mg of methylprednisolone immediately after admission before surgery.
DRUG	Saline	Injection of the same volume of saline immediately after admission before surgery

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2021-08-03
• Last updated: 2022-05-09

Locations

1 site across 1 country: China