Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Children With Global Developmental Delay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in Cognitive Neurodevelopmental Outcome
研究概览
简要总结
This open-label study aims to evaluate the safety and efficacy of umbilical cord blood therapy for children with global developmental delay.
详细描述
Global developmental delay (GDD) is a subset of developmental disabilities defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.
Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.
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
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Global developmental delay
- •Willing to comply with all study procedure
排除标准
- •Medical instability including pneumonia or renal function at enrollment
- •Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
- •Uncontrolled persistent epilepsy
- •Not eligible according to the principal investigator
结局指标
主要结局
Changes in Cognitive Neurodevelopmental Outcome
时间窗: Baseline - 1 month - 3 months - 6 months - 12 months
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (Higher value means better cognitive function, K-BSID-II mental scale raw score: 0 - worst, 178 - best). The investigators will report K-BSID-II Mental Scale raw scores at each assessment time points.
Changes in Cognition
时间窗: Baseline - 6 months - 12 months
Korean Wechsler Preschool and Primay Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best). The investigators will report K-WPPSI at each assessment time points.
次要结局
- Changes in Visual Perception Test(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Muscle Strength(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Language Evaluation(Baseline - 6 months - 12 months)
- Changes in Motor Performance(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Standardized Gross Motor Function(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Functional Independence in Daily Activities(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Motor Neurodevelopmental Outcome(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Functional Performance in Daily Activities(Baseline - 1 month - 3 months - 6 months - 12 months)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital