Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Respiratory outcome: Number of hospitalizations
研究概览
简要总结
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age
详细描述
Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
- •Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial
排除标准
- •Subject whose parent or legal representative does not agree to participate in the study
- •Subject who is considered inappropriate to participate in the study by the investigator
研究组 & 干预措施
PNEUMOSTEM®
A single intratracheal administration of Pneumostem® (10.0 x 10^6 cells/kg)
干预措施: PNEUMOSTEM® (Biological)
normal saline
A single intratracheal administration of normal saline
干预措施: normal saline (Biological)
结局指标
主要结局
Respiratory outcome: Number of hospitalizations
时间窗: 60 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
次要结局
- Number of admissions to Emergency Room (ER)(6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth)
- Bayley Scales of Infant and Toddler Development (Third Edition)(18~24months corrected age, 36~42months after birth)
- Growth measured by Z-score(6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth)
- Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)(6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth)
- Mortality(6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth)
- Deafness or Blindness(24 months corrected age)
- Gross Motor Function Classification System for Cerebral Palsy(24 months corrected age)
- Number of adverse events(6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth)
- Medical treatment records(6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth)