Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- the accumulative duration of oxygen therapy
研究概览
简要总结
This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children with moderate and severe bronchopulmonary dysplasia.
详细描述
Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease.
hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe bronchopulmonary dysplasia.
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
- None
入排标准
- 年龄范围
- 28 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy
- •The legal representative or the participant had signed consent.
排除标准
- •Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation)
- •Participants whose age is more than 1 year old.
研究组 & 干预措施
Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
干预措施: Transplantation of mesenchymal stem cell (Drug)
No Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
干预措施: No Transplantation of Mesenchymal Stem Cell (Drug)
结局指标
主要结局
the accumulative duration of oxygen therapy
时间窗: from the time of diagnosis to the time of stopping oxygen therapy
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
次要结局
- Changes of blood pressure in participants(24 hours after administration)
- Changes of heart rate in participants(24 hours after administration)
研究者
Xia Yunqiu
doctor
Children's Hospital of Chongqing Medical University