Status:
UNKNOWN
Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 cor...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04528550
Start Date
October 1 2020
End Date
December 1 2023
Last Update
July 7 2021
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, China, 200003