NCT02009124撤回2 期
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in clinical symptoms of spinal cord injury after 6 months
研究概览
简要总结
The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.
详细描述
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cases of any type of spinal cord injury
- •age above 12 months.
排除标准
- •presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
- •malignancies
- •bleeding tendencies
- •pneumonia
- •renal failure
- •severe liver dysfunction
- •severe anemia [Hemoglobin < 8]
- •any bone marrow disorder
- •space occupying lesion in brain
- •other acute medical conditions such as respiratory infection and pyrexia.
研究组 & 干预措施
Stem cell
Experimental
autologous bone marrow mononuclear cell transplantation
干预措施: Autologous bone marrow mononuclear cell transplantation (Biological)
Control
No Intervention
Stem cell therapy is not done for this group of spinal cord injury patients
结局指标
主要结局
Change in clinical symptoms of spinal cord injury after 6 months
时间窗: 6 months
次要结局
- Functional independence measure (FIM)(6 months)
研究者
研究点 (2)
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