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
- 14
- 试验地点
- 2
- 主要终点
- Changes in Cognition
研究概览
简要总结
This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic umbilical cord blood therapy for children with global developmental delay.
详细描述
Global developmental delay is 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
研究组 & 干预措施
Umbilical cord blood transplantation
Allogeneic umbilical cord blood will be administered intravenously or intraarterially under non-myeloablative immunosuppression. In case of autologous umbilical cord blood, immunosuppression is not required.
干预措施: Umbilical cord blood transplantation (Procedure)
结局指标
主要结局
Changes in Cognition
时间窗: Baseline - 6 months - 12 months
Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best)
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 Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.)
次要结局
- Changes in Standardized Gross Motor Function(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Motor Performance(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)
- Changes in Motor Neurodevelopmental Outcome(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 Muscle Strength(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Language Evaluation(Baseline - 6 months - 12 months)
- Changes in Brain glucose metabolism(Baseline - 12 months)
- Changes in Visual Perception Test(Baseline - 1 month - 3 months - 6 months - 12 months)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital