A Single-center, Non-randomized, Before-and-after Self Control Study of Bronchial Basal Cell Transplantation for Bronchiectasis Treatment
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CT imaging of dilated bronchi
研究概览
简要总结
Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid secretions. Inflammation results in progressive destruction of the normal lung architecture, in particular the elastic fibers of bronchi. Currently there is no effective drug for bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured cells 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 the key indicator-- the CT imaging of dilated bronchi as well as four secondary indicators including the pulmonary function, laboratory factor level, incidence of acute exacerbation and the patients' self-evaluation.
详细描述
Bronchiectasis is a term for irreversible lung damage resulting from recurrent episodes of infection and inflammation. Bronchial basal cells (BCCs) have been proven with stem cell activity to regenerate bronchi and repair lung damage. In this single-center, non-randomized, self control phase I/II clinical trial, patients' own BCCs will be grown in laboratory before injected to the damaged part of lung tissue. Transplanted BCCs have the potential to replenish the bronchial epithelium and reconstruct respiratory architecture.
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
- •Subjects diagnosed as bronchiectasis.
- •Subjects with at least 6 lung segments affected.
- •Subjects with stable condition for more than 2 weeks.
- •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 syphilis or HIV positive antibody.
- •Subjects with any malignancy.
- •Subjects suffering from 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 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 the upper limit of normal.
- •Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times 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
CT imaging of dilated bronchi
时间窗: 3 day - 6 months
CT image of dilated bronchi will be analyzed.Clinical indicators include the spread of dilation, extent of dilation and the thickness of bronchi wall.
次要结局
- pulmonary function test (FVC)(3 day - 6 months)
- patients' self-evaluation(3 day - 6 months)
- blood gas level（PH）(3 day - 6 months)
- pulmonary function test (DLco)(3 day - 6 months)
- pulmonary function test (FEV1)(3 day - 6 months)
- MRC chronic dyspnea scale(3 day - 6 months)
- St. George's Respiratory Questionnaire (SGRQ) scale(3 day - 6 months)
- incidence of acute exacerbation(3 day-6 months)
- inflammation indicators(3 day - 6 months)
- blood gas level（HCO3）(3 day - 6 months)
- blood gas level（PaCO2）(3 day - 6 months)
- fibrotic factor level(3 day - 6 months)
- pulmonary function test (MMEF)(3 day - 6 months)
- blood gas level（PaO2）(3 day - 6 months)
- 6-minute walk distance test(3 day - 6 months)
- pulmonary function test (MVV)(3 day - 6 months)
研究者
Xiaotian Dai
Principal Investigator
Regend Therapeutics