Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
NCT ID: NCT04528550
Last Updated: 2021-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2020-10-01
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Autologous bone marrow-derived mononuclear cells
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.
Autologous bone marrow-derived mononuclear cells
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
Control
Included patients will receive the same amount of saline through lumbar injection.
Placebo
Included patients will receive the same amount of saline through lumbar injection.
Interventions
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Autologous bone marrow-derived mononuclear cells
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
Placebo
Included patients will receive the same amount of saline through lumbar injection.
Eligibility Criteria
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Inclusion Criteria
* Traumatic spinal cord injury
* ASIA Impairment Scale A-D
* The injury must be within two weeks
* Patients submitted written informed consent
Exclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Xuhua Lu
Director of Traumatic Orthopaedic Department
Principal Investigators
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Xuhua Lu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Changzheng Hospotal
Locations
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Shanghai Changzheng Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202082201
Identifier Type: -
Identifier Source: org_study_id
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