Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
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 (NCT01828957) 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: corrected age of 6, 12,18, 24, 36, 48, and 60 months.
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
- 7 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
- •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® (1.0 x 10^7 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: readmission rate and duration of the hospital stay due to respiratory infection
时间窗: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
次要结局
- Number of adverse events(6, 12, 24,36, 48, and 60 months, corrected age)
- Number of admissions to Emergency Room(6, 12, 18, 24, 36, 48, and 60 months, corrected age)
- Growth measured by Z-score(6, 12, 18, 24, 36, 48, and 60 months, corrected age)
- Deafness or Blindness(24 months, corrected age)
- Significant changes in vital signs(6, 12, 24, 36, 48, and 60 months, corrected age)
- Significant changes in physical exam(6, 12, 24, 36, 48, and 60 months, corrected age)
- Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)(6, 12, 18, 24, 36, 48, and 60 months, corrected age)
- Survival(6, 12, 18, 24, 36, 48, and 60 months, corrected age)
- Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy(24 months, corrected age)