TNFα Monoclonal Antibody for Acute Spinal Cord Injury

• Status: Not yet recruiting
• Trial end date: 2023-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Collaborators: Kunshan First People's Hospital; Kunshan TCM Hospital; Nantong Sixth People's Hospital; Wuxi 904 Hospital; Zhenjiang TCM Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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