TNFα Monoclonal Antibody for Acute Spinal Cord Injury

Sponsor

Shanghai Changzheng Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04988425

Collaborator

The First people's Hospital of Kunshan (Other), Traditional Chinese Medicine Hospital of Kunshan, China (Other), Wuxi 904 Hospital, China (Other), The Sixth People's Hospital of Nantong, China (Other), Zhejiang Provincial Hospital of TCM (Other)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Drug: TNFα Monoclonal Antibody Drug: Methylprednisolone Drug: Saline	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Random grouping

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TNFα monoclonal antibody group Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.	Drug: TNFα Monoclonal Antibody Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
Active Comparator: Methylprednisolone group Injection of 500mg of methylprednisolone immediately after admission before surgery.	Drug: Methylprednisolone Injection of 500mg of methylprednisolone immediately after admission before surgery.
Placebo Comparator: Control group Injection of the same volume of saline immediately after admission before surgery.	Drug: Saline Injection of the same volume of saline immediately after admission before surgery

Arm

Intervention/Treatment

Experimental: TNFα monoclonal antibody group

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

Drug: TNFα Monoclonal Antibody

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

Active Comparator: Methylprednisolone group

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

Drug: Methylprednisolone

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

Placebo Comparator: Control group

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

Drug: Saline

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

Outcome Measures

Primary Outcome Measures

American Spinal Injury Association Impairment Scale(ASIA) [baseline, 1 month, 3 months, 6 months and 12 months post-treatment]
Change in sensory and motor function as measured by the American Spinal Injury Association Impairment Scale (ASIA). The scale ranked from A to E, A indicates the the most severe spinal cord injury and E indicates no neurological deficit.

Secondary Outcome Measures

Incidence of adverse events [1 month post-treatment]
Any abnormal signs, symptoms, findings, or diseases that emerge or worsen relative to baseline in 1 month posttreatment will be recorded as adverse event
Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test [baseline, 3 months, 6 months and 12 months post-treatment]
Change in sensory and motor function will be measured by SSEP and MED test
Residual urine test [baseline, 3 months, 6 months and 12 months post-treatment]
Change in residual urine as measured by ultrasound test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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