NCT03123562已完成2 期
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial
Vinmec Research Institute of Stem Cell and Gene Technology2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- GMFM-88 and GMFM-66 Percentile
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus
详细描述
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus 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
盲法说明
Open Label
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 neonatal icterus
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
研究组 & 干预措施
Stem cell transplantation
Experimental
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
干预措施: Stem cell transplantation (Combination Product)
结局指标
主要结局
GMFM-88 and GMFM-66 Percentile
时间窗: Time Frame: Baseline and 6 months after transplantation
Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile
次要结局
- Number of adverse events(Through study completion, an average of 6 months)
- Change in Muscle tone(Time Frame: Baseline and 6 months after transplantation)
研究者
研究点 (2)
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