A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Indicators for safety
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls 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, expanded 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.);
- •Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
- •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
Indicators for safety
时间窗: 1-6 months
Measured by blood routine test, urine routine test and blood chemistry panels
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
次要结局
- Maximum mid-expiratory flow (MMF)(1-6 months)
- Forced expiratory volume in one second (FEV1)(1-6 months)
- St. George's respiratory questionnaire (SGRQ) scale(1-6 months)
- The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)(1-6 months)
- Imaging of lung by high resolution computed tomography (HR-CT)(1-6 months)
- Forced vital capacity (FVC)(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)
研究者
Xiaotian Dai
principal investigator
Regend Therapeutics