Spinal Cord Injury
Conditions
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 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.
Interventions
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
DRUGPlacebo
Included patients will receive the same amount of saline through lumbar injection.
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A 2:1 ratio of randomization (intervention group: control group) was used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Spinal Injury Association (ASIA) Impairment Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 1 month post-treatment | 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 |
| Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test | baseline, 3 months, 6 months and 12 months post-treatment | Change in sensory and motor function will be measured by SSEP and MED test |
| Residual urine test | baseline, 3 months, 6 months and 12 months post-treatment | Change in residual urine as measured by ultrasound test |
Countries
China
Contacts
Primary ContactXuhua Lu, M.D.
Backup ContactBangke Zhang, M.D.
Outcome results
None listed