NCT02569775已完成2 期
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Vinmec Healthcare System1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Gross Motor Function Measure (GMFM)-66 Percentile
研究概览
简要总结
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.
详细描述
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
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
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy of any types caused by oxygen deprivation.
排除标准
- •Hydrocephalus with ventricular drain
- •Coagulation disorders
- •Allergy to anesthetic agents
- •Severe health conditions such as cancer, failure of heart, lung, liver or kidney
- •Active infections
结局指标
主要结局
Change in Gross Motor Function Measure (GMFM)-66 Percentile
时间窗: 3 months and 6 months after transplantation
GMFM-66 percentile
Change in Total Score of Gross Motor Function Measure (GMFM)-88
时间窗: 3 months and 6 months after transplantation
GMFM-88
次要结局
- Change in Muscle tone(3 months and 6 months after transplantation)
- Number of adverse events(Through study completion, an average of 6 months)
研究者
研究点 (1)
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