NCT02627131已完成2 期
Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial
Vinmec Healthcare System1 个研究点 分布在 1 个国家目标入组 24 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
- 24
- 试验地点
- 1
- 主要终点
- Change in Total Score of Childhood Autism Rating Scale (CARS)
研究概览
简要总结
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.
详细描述
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients 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
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder
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
- •Severe psychiatric disorders
结局指标
主要结局
Change in Total Score of Childhood Autism Rating Scale (CARS)
时间窗: 3 months and 6 months after transplantation
CARS
Number of adverse events
时间窗: Through study completion, an average of 6 months
Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits
次要结局
未报告次要终点
研究者
研究点 (1)
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