Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- American Spinal Injury Association (ASIA) Impairment Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Autologous bone marrow-derived mononuclear cells (Biological)
Control
Included patients will receive the same amount of saline through lumbar injection.
干预措施: Placebo (Drug)
结局指标
主要结局
American Spinal Injury Association (ASIA) Impairment Scale
时间窗: 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).
次要结局
- Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test(baseline, 3 months, 6 months and 12 months post-treatment)
- Residual urine test(baseline, 3 months, 6 months and 12 months post-treatment)
- Incidence of adverse events(1 month post-treatment)
研究者
Xuhua Lu
Director of Traumatic Orthopaedic Department
Shanghai Changzheng Hospital