Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
- Conditions
- Spinal Cord Injury
- Interventions
- Biological: Autologous bone marrow-derived mononuclear cellsDrug: Placebo
- Registration Number
- NCT04528550
- Lead Sponsor
- Shanghai Changzheng Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autologous bone marrow-derived mononuclear cells 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. Control Placebo Included patients will receive the same amount of saline through lumbar injection.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Shanghai Changzheng Hospital
🇨🇳Shanghai, China