Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: Autologous bone marrow-derived mononuclear cells
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 2:1 ratio of randomization (intervention group: control group) was used.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous bone marrow-derived mononuclear cells<br>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. | Biological: Autologous bone marrow-derived mononuclear cells<br>* Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.<br>|
| Placebo Comparator: Control<br>Included patients will receive the same amount of saline through lumbar injection. | Drug: Placebo<br>* Included patients will receive the same amount of saline through lumbar injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline, 1 month, 3 months, 6 months and 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline, 3 months, 6 months and 12 months post-treatment | 
| Residual urine test | Change in residual urine as measured by ultrasound test | baseline, 3 months, 6 months and 12 months post-treatment |