Umbilical Cord Blood Therapy for Cerebral Palsy: a Randomized,Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Changes in Motor Performance
研究概览
简要总结
This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.
详细描述
Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.
On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral Palsy with abnormal muscle tone
- •Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
- •Willing to comply with all study procedure
排除标准
- •Medical instability including pneumonia or renal function at enrollment
- •Presence of known genetic disease
- •Presence of drug hypersensitivity which is related to this study remedy
- •Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
- •Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome
结局指标
主要结局
Changes in Motor Performance
时间窗: Baseline - 1 month - 3 months
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\~100, Higher value means better motor quality). We will report GMPM scores at each assessment time points.
Changes in Standardized Gross Motor Function
时间窗: Baseline - 1 month - 3 months
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100 , Higher value means better gross motor function). We will report GMFM scores at each assessment time points.
次要结局
- Changes in Cognitive Neurodevelopmental Outcome(Baseline - 1 month - 3 months)
- Changes in Motor Neurodevelopmental Outcome(Baseline - 1 month - 3 months)
- Changes in Functional Independence in Daily Activities(Baseline - 1 month - 3 months)
- Changes in Visual Perception Test(Baseline - 1 month - 3 months)
- Changes in Muscle Strength(Baseline - 1 month - 3 months)
- Changes in Functional Performance in Daily Activities(Baseline - 1 month - 3 months)
- Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET(Baseline - 2 weeks)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital