NCT02050776撤回1 期
The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study
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
- Functional Independence Measure
研究概览
简要总结
The purpose of this study was to study the effect of stem cell therapy on the course of the disease in patients with Limb Girdle Muscular Dystrophy.
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females
- •age group of 15 years and above
- •limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
- •Electromyographic and Nerve Conduction velocity findings
排除标准
- •presence of respiratory distress
- •presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
- •malignancies
- •acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
- •pregnancy or breastfeeding
研究组 & 干预措施
Stem Cells
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
Functional Independence Measure
时间窗: 6 months
次要结局
- Manual Muscle Testing(6 months)
研究者
研究点 (2)
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