Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.
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
- 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 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 expiratory volume in one second (FEV1)
时间窗: 1-6 months
One of the indicators for pulmonary function
Forced vital capacity (FVC)
时间窗: 1-6 months
One of the indicators for pulmonary function
次要结局
- FEV1/FVC, MMF, MVV and DLCO(1-6 months)
- 6 minute walk test (6MWT)(1-6 months)
- MMRC(1-6 months)
- SGRQ(1-6 months)
研究者
Guodong HU
Chief Physician
Nanfang Hospital, Southern Medical University