NCT02959333Unknown1 期
Human Amniotic Epithelial Cells for Treatment of Bronchial 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10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
- median time for fistula closure
研究概览
简要总结
Bronchial 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 human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial 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 bronchial fistula by Imaging or bronchoscopic examination
- •typical symptom of bronchial 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
median time for fistula closure
时间窗: 12 weeks
次要结局
- complication(1 year)
研究者
研究点 (1)
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