The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 主要终点
- number of patients with BPD after instillation mesenchymal stem cells
研究概览
简要总结
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
详细描述
This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period.
- Deographic Data and Baseline charateristics of the studied groups were collected:
Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes 2. mesenchymal stem cels dose is 25 million cells/kg 3. Assessment the incidence of BPD after instillation of Mesenchymal stem cells 4. the adverse after instillation of Mesenchymal stem cells
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%
排除标准
- •Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
研究组 & 干预措施
Placebo
0.9% sodium chloride intratracheal instillate on 14 days after birth
干预措施: 0.9% sodium chloride (Drug)
mesenchymal stem cells
mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg
干预措施: mesenchymal stem cells therapy (Other)
结局指标
主要结局
number of patients with BPD after instillation mesenchymal stem cells
时间窗: up to 28 days after birth
incidence of BPD
次要结局
未报告次要终点
研究者
yangjie
Professor
Guangdong Women and Children Hospital