Autologous Transplantation of Bronchial Basal Cells for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 主要终点
- Diffusing capacity of the lung for carbon monoxide (DLCO)
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, the CT imaging, 6 minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale and COPD assessment test (CAT).
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
- •Subjects aged between 40 to
- •Subjects diagnosed with COPD and meet the following standards: a.sustained airway obstruction; b.presence of persistent airflow limitation confirmed by post-bronchodilator FEV1<70% predicted value and FEV1/FVC < 0.
- •Subjects with pulmonary emphysema confirmed by imaging evidence.
- •Subjects with DLCO<80% predicted value in pulmonary function test.
- •Subjects with stable condition for more than 4 weeks.
- •Subjects tolerant to bronchoscopy.
- •Subjects signed informed consent.
排除标准
- •Pregnant or lactating women.
- •Subjects with syphilis or any of HIV, HBV, HCV positive antibody.
- •Subjects with any malignancy.
- •Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension or interstitial lung disease.
- •Subjects suffering from other serious diseases, such as diabetes, myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
- •Subjects with leukopenia (WBC less than 4x10^9 / L) or agranulocytosis (WBC less than 1.5x10^9 / L or neutrophils less than 0.5x10^9 / L) caused by any reason.
- •Subjects with severe renal impairment, serum creatinine> 1.5 times of the upper limit of normal.
- •Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times of the upper limit of normal.
- •Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
- •Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
- •Subjects with a history of alcohol or illicit drug abuse.
- •Subjects accepted by any other clinical trials within 3 months before the enrollment.
- •Subjects with poor compliance, difficult to complete the study.
- •Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
研究组 & 干预措施
Bronchial basal cells
Autologous transplantation of bronchial basal cells
干预措施: Bronchial basal cells (Biological)
结局指标
主要结局
Diffusing capacity of the lung for carbon monoxide (DLCO)
时间窗: 6 months -1 year
An indicator for pulmonary function
次要结局
- Forced expiratory volume measured at the first second (FEV1)(6 months -1 year)
- The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)(6 months -1 year)
- Maximum Voluntary Ventilation (MVV)(6 months -1 year)
- Maximum Mid Expiratory Flow (MMF)(6 months -1 year)
- Imaging of lung structure by high resolution computed tomography (HR-CT)(6 months -1 year)
- Forced vital capacity (FVC)(6 months -1 year)
- 6-minute-walk test (6MWT)(6 months -1 year)
- Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale(6 months -1 year)
- Modified medical research council (mMRC) chronic dyspnea scale to evaluate the level of dyspnea(6 months -1 year)
- COPD Assessment Test (CAT)(6 months -1 year)
研究者
Jieming QU
Principal Investigator
Ruijin Hospital