Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants
详细描述
Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types.
transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with BPD
排除标准
- •parents' rejection
研究组 & 干预措施
transplantation of mesenchymal stem cell
transplantation of mesenchymal stem cell will be given to the infants with BPD.
干预措施: transplantation of mesenchymal stem cell (Drug)
no transplantation of mesenchymal stem cell
transplantation of mesenchymal stem cell will be not given to the infants with BPD.
干预措施: no transplantation of mesenchymal stem cell (Drug)
结局指标
主要结局
death
时间窗: within two years
the infant is dead due to lung disease
次要结局
- Bayley Scales of Infant Development(30 months after birth)
研究者
Chen Long,MD
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University