Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Diffusing capacity of the lung for carbon monoxide (DLCO)
研究概览
简要总结
Bronchiectasis is a disease resulted from progressive destruction of bronchi with no effective drug for its treatment. In this study, we intends to carry out a randomized, single-blinded, controlled pilot clinical trial at 1/2 phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue via 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 airway clearance. The investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, 6 minute walk distance (6MWD), the distance-saturation product (DSP), St. George's Respiratory Questionnaire (SGRQ), FACED scoring, bronchiectasis severity index (BSI) , and high-resolution computed tomography (HRCT) at week 4, week 12, and week 24 after cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The opaque sealed envelope method was used to conceal the allocation sequence. Both patients and investigators, except for the bronchoscopy operators, remained masked to the treatment assignment for the duration of the study. Only the investigators who performed the bronchoscopy were unblinded. The non-blinded investigators should not disclose any blind information to other investigators, participants, care providers, or outcomes assessors.
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
- •Subjects diagnosed as bronchiectasis.
- •Subjects with a DLCO < 80% predicted value.
- •Subjects with stable condition for more than 2 weeks.
- •Subjects can do pulmonary function tests.
- •Subjects can tolerate bronchoscopy.
- •Subjects signed informed consent.
排除标准
- •Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
- •Subjects with positive serological tests for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis (HBV carriers and patients with stable chronic hepatitis B could be accepted if titers of HBV DNA < 500 IU/mL or copies < 1000 copies/mL; patients with curative hepatitis C were eligible if HCV RNA tests were negative).
- •Subjects with any malignancy.
- •Subjects with any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe COPD.
- •Subjects with other serious diseases, such as poorly controlled 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.
结局指标
主要结局
Diffusing capacity of the lung for carbon monoxide (DLCO)
时间窗: Week 4, 12, and 24 after treatment
An indicator of pulmonary function
次要结局
- Forced vital capacity (FVC)(Week 4, 12, and 24 after treatment)
- Maximum Voluntary Ventilation (MVV)(Week 4, 12, and 24 after treatment)
- 6 minute walk distance (6MWD) and distance saturation product (DSP)(Week 4, 12, and 24 after treatment)
- High resolution computed tomography (HR-CT) imaging of lung(Week 4, 12, and 24 after treatment)
- Forced expiratory volume measured at the first second (FEV1)(Week 4, 12, and 24 after treatment)
- The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)(Week 4, 12, and 24 after treatment)
- Maximum Mid Expiratory Flow (MMEF)(Week 4, 12, and 24 after treatment)
- St. George's Respiratory Questionnaire (SGRQ)(Week 4, 12, and 24 after treatment)
- FACED scoring(Week 4, 12, and 24 after treatment)
- Bronchiectasis Severity Index (BSI)(Week 4, 12, and 24 after treatment)
- Safety outcomes: adverse events(Through study completion, an average of 24 weeks)
研究者
Jieming QU
Principal Investigator
Ruijin Hospital