TNFα Monoclonal Antibody for Acute Spinal Cord Injury
Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedMay 9, 2022
May 1, 2022
12 months
July 7, 2021
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
American Spinal Injury Association Impairment Scale(ASIA)
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.
baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary Outcomes (3)
Incidence of adverse events
1 month post-treatment
Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
baseline, 3 months, 6 months and 12 months post-treatment
Residual urine test
baseline, 3 months, 6 months and 12 months post-treatment
Study Arms (3)
TNFα monoclonal antibody group
EXPERIMENTALSubcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
Methylprednisolone group
ACTIVE COMPARATORInjection of 500mg of methylprednisolone immediately after admission before surgery.
Control group
PLACEBO COMPARATORInjection of the same volume of saline immediately after admission before surgery.
Interventions
Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
Injection of 500mg of methylprednisolone immediately after admission before surgery.
Injection of the same volume of saline immediately after admission before surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Changzheng Hospitallead
- The First People's Hospital of Kunshancollaborator
- Traditional Chinese Medicine Hospital of Kunshan, Chinacollaborator
- 904th Hospital of the Joint Logistics Support Force of the PLAcollaborator
- The Sixth People's Hospital of Nantong, Chinacollaborator
- Zhejiang Provincial Hospital of TCMcollaborator
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, 200003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuhua Lu, M.D.
Shanghai Changzheng Hospotal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Random grouping
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Traumatic Orthopaedic Department
Study Record Dates
First Submitted
July 7, 2021
First Posted
August 3, 2021
Study Start
September 1, 2022
Primary Completion
August 30, 2023
Study Completion
August 30, 2023
Last Updated
May 9, 2022
Record last verified: 2022-05