Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Oxygen requirement 3 days after transplantation
研究概览
简要总结
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
详细描述
Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Weeks 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
- •Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
排除标准
- •Patients with severe congenital diseases
- •Patients with IVH more than 3 grade
- •Patients with severe sepsis
- •Patients with active pulmonary hemorrhage
研究组 & 干预措施
Mesenchymal stem cell
Human Umbilical Cord-derived Mesenchymal stem cell in the saline
干预措施: Human Umbilical Cord-derived Mesenchymal stem cell (Drug)
placebo
saline without mesenchymal stem cell
干预措施: placebo (Drug)
结局指标
主要结局
Oxygen requirement 3 days after transplantation
时间窗: 3 days
Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %
次要结局
- Oxygen requirement 7 days after transplantation(7 days)
- Duration of ventilator dependence(up to 36 weeks PMA)
- Incidence of severe BPD(up to 36 weeks PMA)
- Survival rate(up to 36 weeks PMA)
- Temperature(3 days)
- Heart rate(3 days)
- Respiratory rate(3 days)
- Duration of CPAP treatment(up to 36 weeks PMA)
- Percentage of participants treated with steroids for weaning from ventilator(up to 36 weeks PMA)
- Growth velocity (Z-score)(up to 36 weeks PMA)
- bronohoalveolar lavage (BAL) cytokine level(7 days)
- The severity of BPD in X-ray patterns(7 days)