TNFα Monoclonal Antibody for Acute Spinal Cord Injury

May 4, 2022 updated by: Xuhua Lu, Shanghai Changzheng Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200003
        • Shanghai Changzheng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 1 month, 3 months, 6 months and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 3 months, 6 months and 12 months post-treatment
Residual urine test
Time Frame: baseline, 3 months, 6 months and 12 months post-treatment
Change in residual urine as measured by ultrasound test
baseline, 3 months, 6 months and 12 months post-treatment
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
1 month post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Collaborators

Zhejiang Provincial Hospital of TCM
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

Investigators

  • Principal Investigator: Xuhua Lu, M.D., Shanghai Changzheng Hospotal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 31, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021070701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be available through email when requested

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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