NCT02961725Unknown1 期
Umbilical Cord Mesenchymal Stem Cells for Treatment of Bronchopleural Fistula
The Second Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- closure of the fistula
研究概览
简要总结
Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.
The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to investigate the application of umbilical cord mesenchymal stem cells in the treatment of bronchopleural fistula.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with bronchopleural fistula by imaging or bronchoscopic examination
- •typical symptom of bronchopleural fistula, such as fever, cough, purulent sputum, weight loss...
- •patients present compromised conditions, who can only accept a conservative treatment.
排除标准
- •absolute contraindication of bronchoscopic examination and treatment
- •with previous treatment of cell therapy, including stem cells.
结局指标
主要结局
closure of the fistula
时间窗: 24 weeks
median time for fistula closure
次要结局
- complication(1 year)
研究者
研究点 (1)
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