TNFα Monoclonal Antibody for Acute Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04988425
• Other study ID #: 2021070701
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Changzheng Hospital
• Contact: Xuhua Lu, M.D.
• Phone: +862181885793
• Email: xuhualu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• TNFa Monoclonal Antibody
Subcutaneous injection of 50mg of TNFa monoclonal antibody immediately after admission before surgery.
• Methylprednisolone
Injection of 500mg of methylprednisolone immediately after admission before surgery.
• Saline
Injection of the same volume of saline immediately after admission before surgery

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	The First people's Hospital of Kunshan, The Sixth People's Hospital of Nantong, China, Traditional Chinese Medicine Hospital of Kunshan, China, Wuxi 904 Hospital, China, Zhejiang Provincial Hospital of TCM

Country where clinical trial is conducted

China, 

Outcome

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