Clinical trial NCT04988425: TNFα Monoclonal Antibody for Acute Spinal Cord Injury
Official title: Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Kunshan
name: Traditional Chinese Medicine Hospital of Kunshan, China
name: 904th Hospital of the Joint Logistics Support Force of the PLA
name: The Sixth People's Hospital of Nantong, China
name: Zhejiang Provincial Hospital of TCM
First posted: 2021-08-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: American Spinal Injury Association Impairment Scale(ASIA)
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1 month post-treatment
measure: Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
timeFrame: baseline, 3 months, 6 months and 12 months post-treatment
measure: Residual urine test
timeFrame: baseline, 3 months, 6 months and 12 months post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospotal
name: Xuhua Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: