NCT03392467已完成2 期
A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe 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
- 60
- 试验地点
- 2
- 主要终点
- Percentage of subjects who have severe BPD or are dead
研究概览
简要总结
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.
详细描述
Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 13 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at screening and randomization
- •23 weeks to < 25 weeks of gestational age
- •500g to 1,250g body weight at birth
- •premature infant within postnatal 13 days of age
- •use ventilator with ventilation rate >12 breaths/min or oxygen supply > 25%, or use high frequency ventilator (HFV)
- •at IP administration
- •premature infant within postnatal 5 to 14 days of age
- •No improvement in ventilator setting 24 hours prior to administration of IP
排除标准
- •subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
- •subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
- •subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
- •subject with serious sepsis as active infection or shock due to sepsis
- •subject with grade 3 or 4 of bilateral intraventricular hemorrhage
- •at screening, subject with active pulmonary hemorrhage or active air leak syndrome
- •subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration
- •subject who is expected to be treated with surfactant within 24 hours prior to IP administration
- •subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).
- •subject who have previously participated in other clinical trials
- •subject who is considered ineligible by investigator due to other medical reasons
研究组 & 干预措施
Placebo
Placebo Comparator
normal saline
干预措施: Placebo (Other)
PNEUMOSTEM
Experimental
human umbilical cord blood derived mesenchymal stem cell (hUCB-MSC)
干预措施: PNEUMOSTEM (Biological)
结局指标
主要结局
Percentage of subjects who have severe BPD or are dead
时间窗: 36 weeks postmenstrual age (PMA)
Percentage of subjects who have severe BPD or are dead
次要结局
- Percentage of subjects who have moderate/severe BPD or are dead(36 weeks PMA)
- Percentage of subjects by severity of BPD(prenatal 28 days/36 weeks PMA)
- Percentage of subjects in death due to lung disease(prenatal 28 days/36 weeks PMA and study end timepoint)
- intubation duration(up to 24 weeks)
- ventilation duration(up to 24 weeks)
- continuous positive airway pressure (CPAP) treatment duration(up to 24 weeks)
- treatment duration with supplemental oxygen(up to 24 weeks)
- % of subjects treated with steroid for weaning ventilator(up to 24 weeks)
- Retinopathy of prematurity (ROP) with stage III or higher(up to 24 weeks)
- number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy(up to 24 weeks)
- z-score(up to 24 weeks (visit 10))
- days in hospitalization(up to 24 weeks)
- changes in tracheal suction fluid examination(from screening to 7 days after IP administration (visit 5))
研究者
研究点 (2)
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