Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Monitoring adverse events
研究概览
简要总结
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with acquired brain injury.
详细描述
Acquired brain injury (ABI) means brain damage caused by events after birth, rather than as part of a genetic or congenital disorders. Those with ABI suffer from cognitive, physical, or behavioral impairments limiting their activity and participation in society. ABI results from traumatic or non-traumatic brain injury due to internal or external source (e.g. infection, brain tumor, hypoxia). Preclinical studies regarding cell therapy in animal models of ABI showed improvements of neurological dysfunction. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for patients with ABI.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired brain injury
- •Duration: over 12 months
- •Willing to comply with all study procedure
排除标准
- •Medical instability including pneumonia or renal function at enrollment
- •Uncontrolled persistent epilepsy
- •Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
- •Not eligible according to the principal investigator
结局指标
主要结局
Monitoring adverse events
时间窗: 12 months
次要结局
- Changes in motor neurodevelopmental outcome(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in brain glucose metabolism(Baseline - 12 months)
- Changes in cognitive neurodevelopmental outcome(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in brain white matter integrity(Baseline - 12 months)
- Changes in functional performance in daily activities(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 motor performance(Baseline - 1 month - 3 months - 6 months - 12 months)
研究者
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital