Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assess the change in autism level by using tools
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 combined with Psychological Therapy and Rehabilitation for Autism children
详细描述
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018
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
盲法说明
Open Label
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V 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
- •Rett syndrome
- •Fragile X syndrome
结局指标
主要结局
Assess the change in autism level by using tools
时间窗: 6 months and 12 months after transplantation
using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism
Evaluate the safety of therapy by record number of adverse events
时间窗: Through study completion, an average of 12 months
次要结局
未报告次要终点