NCT02027246撤回1 期
Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in clinical symptoms
研究概览
简要总结
The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.
详细描述
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Months 至 63 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cases of any type of chronic Spinal cord injury
- •Age above 6 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
- •other acute medical conditions such as respiratory infection
- •pregnancy and lactation
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)
结局指标
主要结局
Change in clinical symptoms
时间窗: 6 months
clinical symptoms were assessed based on the observation of the experts
次要结局
- Functional Independence Measure (FIM)(6 months)
研究者
研究点 (2)
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