Spinal Cord InjuriesPhase 1/2NCT04988425
TNFα Monoclonal Antibody for Acute Spinal Cord Injury
A Phase 1/2 study testing TNFα Monoclonal Antibody, Methylprednisolone and Saline in people with Spinal Cord Injuries, run by Shanghai Changzheng Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- TNFα Monoclonal Antibody, Methylprednisolone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- TNFα Monoclonal Antibody, Methylprednisolone, Saline
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNFα Monoclonal AntibodyDrug
Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
Injection of 500mg of methylprednisolone immediately after admission before surgery.
SalineDrug
Injection of the same volume of saline immediately after admission before surgery
| Study group | Role | What they receive |
|---|---|---|
| TNFα monoclonal antibody group | Experimental | Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery. Receives: Drug: TNFα Monoclonal Antibody |
| Methylprednisolone group | Active comparator | Injection of 500mg of methylprednisolone immediately after admission before surgery. Receives: Drug: Methylprednisolone |
| Control group | Placebo comparator | Injection of the same volume of saline immediately after admission before surgery. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary outcomes (3)
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
Measured: 1 month post-treatment
Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
Change in sensory and motor function will be measured by SSEP and MED test
Measured: baseline, 3 months, 6 months and 12 months post-treatment
Residual urine test
Change in residual urine as measured by ultrasound test
Measured: baseline, 3 months, 6 months and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Sep 2022 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Kunshan, Kunshan Hospital of Traditional Chinese Medicine, 904th Hospital of the Joint Logistics Support Force of the PLA, The Sixth People's Hospital of Nantong, China, Zhejiang Provincial Hospital of TCM
- Responsible party
- Principal investigator, Xuhua Lu, Shanghai Changzheng Hospital
- Investigators
- Xuhua Lu, M.D., Principal investigator, Shanghai Changzheng Hospotal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988425
- Sponsor's protocol ID
- 2021070701
- Status last verified
- May 2022
- First submitted
- 7 Jul 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be available through email when requested
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04988425
- Acronym / sponsor ID
- 2021070701
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- The First People's Hospital of Kunshan, Kunshan Hospital of Traditional Chinese Medicine, 904th Hospital of the Joint Logistics Support Force of the PLA, The Sixth People's Hospital of Nantong, China, Zhejiang Provincial Hospital of TCM
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TNFα monoclonal antibody group | Experimental | Drug: TNFα Monoclonal AntibodySubcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery. |
| Methylprednisolone group | Active comparator | Drug: MethylprednisoloneInjection of 500mg of methylprednisolone immediately after admission before surgery. |
| Control group | Placebo comparator | Drug: SalineInjection of the same volume of saline immediately after admission before surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNFα Monoclonal AntibodySubcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery. | Drug | TNFα monoclonal antibody group |
| MethylprednisoloneInjection of 500mg of methylprednisolone immediately after admission before surgery. | Drug | Methylprednisolone group |
| SalineInjection of the same volume of saline immediately after admission before surgery | Drug | Control group |
Primary outcome
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.
3 secondary outcomes
Incidence of adverse events
Time frame: 1 month post-treatment
Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided. IPD will be available through email when requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuhua Lu, M.D. principal investigator
Shanghai Changzheng Hospotal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNFα Monoclonal Antibody, Methylprednisolone and Saline in people with Spinal Cord Injuries, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Lu, M.D. (+862181885793, xuhualu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Spinal Injury Association Impairment Scale(ASIA) (time frame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.