Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diffusion capacity of CO (DLCO)
研究概览
简要总结
Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed phase I clinical trial by transplantation of autologous bronchial basal cells on patients suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6 months, 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
- 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 COPD, BE or PF according to the guideline;
- •Clinically stable for more than 4 weeks;
- •Tolerant to fiberoptic bronchoscopy test;
- •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 investigators.
结局指标
主要结局
Diffusion capacity of CO (DLCO)
时间窗: 1-6 months
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
Forced expiratory volume in one second (FEV1)
时间窗: 1-6 months
One of the indicators in pulmonary function test, a marker to assess airway obstruction
次要结局
- Maximum mid-expiratory flow (MMF)(1-6 months)
- Maximum voluntary ventilation (MVV)(1-6 months)
- Forced vital capacity (FVC)(1-6 months)
- Modified medical research council (MMRC) chronic dyspnea scale(1-6 months)
- 6-minute-walk test (6MWT)(1-6 months)
- St. George's respiratory questionnaire (SGRQ) scale(1-6 months)
- Imaging of lung by high resolution computed tomography (HR-CT)(1-6 months)
- The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)(1-6 months)