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TNFα Monoclonal Antibody for Acute Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04988425
Recruitment Status : Not yet recruiting
First Posted : August 3, 2021
Last Update Posted : May 9, 2022
Sponsor:
Collaborators:
The First people's Hospital of Kunshan
Traditional Chinese Medicine Hospital of Kunshan, China
Wuxi 904 Hospital, China
The Sixth People's Hospital of Nantong, China
Zhejiang Provincial Hospital of TCM
Information provided by (Responsible Party):
Xuhua Lu, Shanghai Changzheng Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. American Spinal Injury Association Impairment Scale(ASIA) [ Time Frame: 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 :
  1. Incidence of adverse events [ Time Frame: 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

  2. Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test [ Time Frame: baseline, 3 months, 6 months and 12 months post-treatment ]
    Change in sensory and motor function will be measured by SSEP and MED test

  3. Residual urine test [ Time Frame: baseline, 3 months, 6 months and 12 months post-treatment ]
    Change in residual urine as measured by ultrasound test



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04988425


Contacts
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Contact: Xuhua Lu, M.D. +862181885793 xuhualu@hotmail.com
Contact: Bangke Zhang, M.D. +8618301783716 zbk12345@163.com

Locations
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China
Shanghai Changzheng Hospital
Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
The First people's Hospital of Kunshan
Traditional Chinese Medicine Hospital of Kunshan, China
Wuxi 904 Hospital, China
The Sixth People's Hospital of Nantong, China
Zhejiang Provincial Hospital of TCM
Investigators
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Principal Investigator: Xuhua Lu, M.D. Shanghai Changzheng Hospotal
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Responsible Party: Xuhua Lu, Director of Traumatic Orthopaedic Department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT04988425    
Other Study ID Numbers: 2021070701
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be available through email when requested

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Antibodies
Antibodies, Monoclonal
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents