Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events
研究概览
简要总结
To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia
详细描述
The purpose of this study is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in 10 patients with bronchopulmonary dysplasia at Vinmec International Hospital, Hanoi, Vietnam
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
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old
- •Gender: either sex
- •Year old < 6 months
- •Weight ≥ 2 kg
- •Agree to participate in the study.
排除标准
- •Severe congenital malformation.
- •Other severe conditions (active pulmonary bleeding, evidence of active infections).
研究组 & 干预措施
Stem cell transplantation
1 million umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 1 week after the first transplantation
干预措施: stem cell transplantation (Combination Product)
结局指标
主要结局
Adverse events and serious adverse events
时间窗: during 9 months post treatment
Incidence of the adverse events or serious adverse events after transplantation
The proportion of patients win from oxygen
时间窗: during 9 months post treatment
To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.
次要结局
- The lung fibrosis(at 6 months post treatment)