TNFα Monoclonal Antibody for Acute Spinal Cord Injury

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

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

Sponsors & Collaborators

• The First People's Hospital of Kunshan

  collaborator OTHER

• Traditional Chinese Medicine Hospital of Kunshan, China

  collaborator UNKNOWN

• 904th Hospital of the Joint Logistics Support Force of the PLA

  collaborator OTHER

• The Sixth People's Hospital of Nantong, China

  collaborator UNKNOWN

• Zhejiang Provincial Hospital of TCM

  collaborator OTHER

• Shanghai Changzheng Hospital

  lead OTHER

Principal Investigators

• Xuhua Lu, M.D. · Shanghai Changzheng Hospotal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2023-08-30

Completion

2023-08-30

Countries

• China

Study Locations