NCT02381366已完成1 期
A Phase I/II, Open-Label Dose Escalation Trial to Evaluate the Safety and Efficacy of Two Dose Levels of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD)
Medipost America Inc.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of participants with adverse reactions for 84 days after treatment
研究概览
简要总结
PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of PNEUMOSTEM® in premature infants at high risk for BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
- •A subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks)
- •A subject whose birth weight is between 500g and 1000g, inclusive
- •A subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
- •A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment
- •A subject whose parent/guardian can give a written informed consent
排除标准
- •A subject who has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect (VSD)
- •A subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly
- •A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)
- •A subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, HIV, etc.)
- •A subject who has evidence of severe sepsis or septic shock due to an active infection at Screening
- •A subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration
- •A subject who was administered surfactant within 24 hours before study drug administration
- •A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage
- •A subject who has active pulmonary hemorrhage or an active air leak syndrome at Screening
- •A subject who is currently participating in any other interventional clinical trial
- •A subject who is, in the opinion of the Principal Investigator, considered inappropriate for the trial due to any reasons other than those listed above
研究组 & 干预措施
PNEUMOSTEM®
Experimental
Dose A: PNEUMOSTEM® 10 million cells per kg Dose B: PNEUMOSTEM® 20 million cells per kg
干预措施: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Number of participants with adverse reactions for 84 days after treatment
时间窗: 84 days
次要结局
- Bayley Scales of Infant and Toddler Development between 84 days after treatment until 20 months of corrected age(Between 84 days after treatment and 20 months of corrected age)
- Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA)(36 weeks PMA)
- Number of participants with adverse reactions between 84 days after treatment and 20 months of corrected age(Between 84 days after treatment and 20 months of corrected age)
- Hospital Re-admission between 84 days after treatment until 20 months of corrected age(Between 84 days after treatment and 20 months of corrected age)
研究者
研究点 (2)
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