NCT02274428已完成1 期
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- unsuspected death or anaphylactic shock
研究概览
简要总结
Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)
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
- 23 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IVH grade 3-4, confirmed with brain ultrasonogram
- •within 7 days after IVH diagnosis
排除标准
- •severe congenital anomaly
- •intrauterine intracranial bleeding
- •intracranial infection
- •severe congenital infection
- •active and uncontrolled infection, CRP>10mg/dl
- •Platelet count <50,000/ml
- •severe metabolic acidosis (PH<7.1, BE<-20)
研究组 & 干预措施
pneumostem group
Other
single arm, pneumostem treated infants
干预措施: pneumostem (Drug)
结局指标
主要结局
unsuspected death or anaphylactic shock
时间窗: within 6 h after pneumostem transplantation
次要结局
- Death or hydrocephalus required shunt operation(First discharge home, maximum time frame : 1 year)
研究者
Won Soon Park
Professor
Samsung Medical Center
研究点 (1)
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