NCT01828957已完成2 期
Randomized, Double-blind, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pneumostem® Versus a Control Group for Treatment of Bronchopulmonary Dysplasia in Premature Infants
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
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
- 5 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 5 - 14 days since birth
- •Fetal gestational age: ≥23 weeks and <29 weeks
- •Birth weight: ≥500g and ≤1250g
- •Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of > 12 breath/min and > 25% oxygen
- •Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment
- •Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial
排除标准
- •Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus
- •Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
- •Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
- •Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
- •Patient withCRP > 30 mg/dL; Severe sepsis or shock
- •Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug
- •Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug
- •Patient with severe intracranial hemorrhage ≥ grade 3 or 4
- •Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening
- •Patient with a history of participating in other clinical studies
- •Patient who is allergic to Gentamicin
- •Patient who is considered inappropriate to participate in the study by the investigator
研究组 & 干预措施
Pneumostem®
Experimental
A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
干预措施: Pneumostem® (Biological)
normal saline
Placebo Comparator
A single intratracheal administration of normal saline
干预措施: Normal Saline (Other)
结局指标
主要结局
Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA
时间窗: 36 weeks PMA
Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA
次要结局
- Incidence of pneumothorax that require intubation(Week 24)
- Survival rate(28-days since birth, 36 weeks PMA, and termination of the trial)
- Incidence of adverse events(Week 24)
- Intubation duration(36 weeks PMA)
- Duration of ventilator dependence(Week 24)
- Incidence of Retinopathy of Prematurity (ROP) of Grade III or more(Week 24)
- Retinopathy of Prematurity (ROP) that require treatment with avastin or laser(Week 24)
- Postnatal steroid use (%) for the purpose of ventilator weaning(Week 24)
- Cumulative duration of oxygen use(Week 24)
- Length of stay prior to the first discharge from the hospital(duration of the hospital stay, an expected average of approximately 3 months since birth)
- Duration of CPAP treatment(Week 24)
- Growth velocity (Z-score)(Week 24)
- Incidence of BPD(28-days since birth)
- Clinically significant laboratory findings(Week 24)
- Incidence of moderate to severe pulmonary hemorrhage(Week 24)
- Incidence of intraventricular hemorrhage of grade 3 or more(Week 24)
研究者
研究点 (2)
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