Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 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 with/without cartilage defects
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;
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.
研究组 & 干预措施
Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells
Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells
干预措施: Patients treated according to current clinical protocols (Other)
Patients with tracheal/laryngeal stenosis receiving standard treatment
Patients with tracheal/laryngeal stenosis receiving standard surgical treatment
干预措施: Patients treated according to current clinical protocols (Other)
Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells
Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells
干预措施: Olfactory mucosa-derived mesenchymal stem cells (Biological)
结局指标
主要结局
Number of patients who didn't require the repeated surgical interventions
时间窗: 1 year
Relative number of patients who didn't require the repeated surgical interventions after MSC therapy
次要结局
未报告次要终点