Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Forced vital capacity (FVC)
研究概览
简要总结
Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 40 to 75;
- •Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination);
- •Clinically stable for more than 4 weeks;
- •Tolerant to bronchofiberscope;
- •Written informed consent signed.
排除标准
- •Pregnant or lactating women;
- •Patients positive for syphilis, HIV;
- •Patients with malignant tumor;
- •Patients with serious or significant pulmonary infection and need anti-infection treatment;
- •Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
- •Patients with a history of abusing alcohol and illicit drug;
- •Patients participated in other clinical trials in the past 3 months;
- •Patients assessed as inappropriate to participate in this clinical trial by investigator.
结局指标
主要结局
Forced vital capacity (FVC)
时间窗: 1-6 months
An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation
Forced expiratory volume in one second (FEV1)
时间窗: 1-6 months
An indicator for pulmonary function test to assess airway obstruction
次要结局
- Diffusion capacity of CO (DLCO)(1-6 months)
- Maximum mid-expiratory flow (MMF)(1-6 months)
- St. George's respiratory questionnaire (SGRQ) scale(1-6 months)
- Maximum voluntary ventilation (MVV)(1-6 months)
- Modified medical research council (MMRC) chronic dyspnea scale(1-6 months)
- 6-minute-walk test (6MWT)(1-6 months)
- The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)(1-6 months)
研究者
Xiaohe Zheng
Chief Physician
First Affiliated Hospital of Shantou University Medical College