Spinal Cord InjuryPhase 2NCT04528550
Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
A Phase 2 study testing Autologous bone marrow-derived mononuclear cells in people with Spinal Cord Injury, 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 intrathecal transplantation of autologous bone marrow-derived mononuclear 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 Injury
- What is being tested?
- Autologous bone marrow-derived mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Dec 2023
- Phase
- Phase 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 anemia, coagulopathy, and other known blood system diseases
- Patients with malignant tumour
- Patients with neurodegenerative diseases, or any neuropathies
- Patients with ankylosing spondylitis
- Patients with a previous history of spinal surgery
- Patients who are pregnant or possibly pregnant
- Patients with psychiatric, addictive or any other mental disorders that can not give a truly informed consent
- Patients who are participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, 200003
Xiaoguang Li, M.D., 86-21-81885045, Chzhhospital@163.com
About this study
Official title: Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear 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). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.
- Conditions
- Spinal Cord Injury
- Being tested
- Autologous bone marrow-derived mononuclear cells, Placebo
- 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.
Autologous bone marrow-derived mononuclear cellsBiological
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
PlaceboDrug
Included patients will receive the same amount of saline through lumbar injection.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow-derived mononuclear cells | Experimental | Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection in acute phase. Each included patient will receive a single dose of 100 million autologous bone marrow-derived mononuclear cells. Receives: Biological: Autologous bone marrow-derived mononuclear cells |
| Control | Placebo comparator | Included patients will receive the same amount of saline through lumbar injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association (ASIA) Impairment Scale
Change in sensory and motor function as measured by the American Spinal Injury Association (ASIA) Impairment Scale. The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal).
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 post-treatment 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 posted27 Aug 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 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 InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2:1 ratio of randomization (intervention group: control group) was used.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuhua Lu, Shanghai Changzheng Hospital
- Investigators
- Xuhua Lu, Principal investigator, Shanghai Changzheng Hospotal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528550
- Sponsor's protocol ID
- 202082201
- Status last verified
- Jul 2021
- First submitted
- 24 Aug 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04528550
- Acronym / sponsor ID
- 202082201
- Conditions
- Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Aug 2020 (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 intrathecal transplantation of autologous bone marrow-derived mononuclear 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). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2:1 ratio of randomization (intervention group: control group) was used.
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow-derived mononuclear cells | Experimental | Biological: Autologous bone marrow-derived mononuclear cellsIntrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection in acute phase. Each included patient will receive a single dose of 100 million autologous bone marrow-derived mononuclear cells. |
| Control | Placebo comparator | Drug: PlaceboIncluded patients will receive the same amount of saline through lumbar injection. |
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 (15 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 |
|---|---|---|
| Autologous bone marrow-derived mononuclear cellsIntrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection. | Biological | Autologous bone marrow-derived mononuclear cells |
| PlaceboIncluded patients will receive the same amount of saline through lumbar injection. | Drug | Control |
Primary outcome
American Spinal Injury Association (ASIA) Impairment Scale
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 (ASIA) Impairment Scale. The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal).
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 7 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 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 2 study testing Autologous bone marrow-derived mononuclear cells in people with Spinal Cord Injury, 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 15 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 7 Jul 2021. 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 phase mean?
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. (86-21-81885793, 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 (ASIA) Impairment Scale (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 7 Jul 2021.