Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The relations between the cytokine concentrations in the BAL fluid and PAP.
研究概览
简要总结
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Week 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe BPD, defined by the National Institute of Child Health and Human Development workshop, who conventional therapies (including furosemide and theophylline, and HFO ventilation) has failed
排除标准
- •severe congenital anomalies
- •severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.
研究组 & 干预措施
Mesenchymal stem cells
the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
干预措施: ucMSCs (Biological)
Control
Normal saline
干预措施: Normal saline (Other)
结局指标
主要结局
The relations between the cytokine concentrations in the BAL fluid and PAP.
时间窗: Up to 20 weeks
To examine the relations between the cytokine concentrations in the BAL fluid and PAP.
次要结局
- The severity score of BPD ranging from 0 to 6 on the serial chest radiographs(6 months to 1 year)