TNFα Monoclonal Antibody for Acute Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Random grouping

Study Groups

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TNFα monoclonal antibody group

Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.

Group Type EXPERIMENTAL

TNFα Monoclonal Antibody

Intervention Type DRUG

Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.

Methylprednisolone group

Injection of 500mg of methylprednisolone immediately after admission before surgery.

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Injection of 500mg of methylprednisolone immediately after admission before surgery.

Control group

Injection of the same volume of saline immediately after admission before surgery.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Injection of the same volume of saline immediately after admission before surgery

Interventions

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TNFα Monoclonal Antibody

Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.

Intervention Type DRUG

Methylprednisolone

Injection of 500mg of methylprednisolone immediately after admission before surgery.

Intervention Type DRUG

Saline

Injection of the same volume of saline immediately after admission before surgery

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No