Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Number of patients who didn't require the repeated surgical interventions
研究概览
简要总结
The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis
详细描述
Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis.
Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of chronic laryngeal or tracheal stenosis;
- •absence of cartilage damage.
排除标准
- •refuse of patient to participate in the trial;
- •acute infectious diseases;
- •chronic mental disorders with severe manifestations;
- •pregnancy/lactation;
- •intercurrent severe chronic diseases;
- •HIV, Hepatites B/C;
- •active tuberculosis;
- •alcohol use disorder/drug addiction;
- •cachexia of any origin;
- •malignant neoplasms.
结局指标
主要结局
Number of patients who didn't require the repeated surgical interventions
时间窗: 1 year
次要结局
- Tracheostomy decannulation(6 month)
研究者
Andrei Y. Hancharou
Head of the Laboratory for Immunology and Cellular Biotechnology,
The Republican Research and Practical Center for Epidemiology and Microbiology