NCT02673788Unknown不适用
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- newly developed brain tumor
研究概览
简要总结
This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
排除标准
- •Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
结局指标
主要结局
newly developed brain tumor
时间窗: until 2 years old (corrected age)
Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.
次要结局
- Developmental disability(until 2 years old (corrected age))
- Bayley score (MDI, PDI)(until 2 years old (corrected age))
- Cerebral palsy(until 2 years old (corrected age))
研究者
Won Soon Park
Professor
Samsung Medical Center
研究点 (1)
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