Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Readmission rate
研究概览
简要总结
This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.
详细描述
Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 5 Years（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 hUC-MSCs PhaseⅠ clinical trial
- •Subject with a written consent form signed by a legal representative or a parent
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 the study by the investigator
研究组 & 干预措施
Mesenchymal Stem Cell
A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)
干预措施: transplantation of hUC-MSCs (Drug)
结局指标
主要结局
Readmission rate
时间窗: within two years
Duration of the hospital stay due to respiratory infection
时间窗: within two years
次要结局
- Growth measured by Z-score(within two years)
- Rate of Survival(within two years)
- Incidence of Tumorigenicity(within two years)
- Number of neurological developmental delay(within two years)
- Number of blindness and deafness(within two years)
研究者
Xia Yunqiu
Director
Children's Hospital of Chongqing Medical University