Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis
- Conditions
- Bronchiectasis
- Interventions
- Biological: Bronchial basal cells (BBCs)Procedure: Bronchoscopic airway clearance treatment （B-ACT）
- Registration Number
- NCT03655808
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cell treatment group Bronchoscopic airway clearance treatment （B-ACT） Patients receive both autologous BBCs transplantation and B-ACT therapy. Control group Bronchoscopic airway clearance treatment （B-ACT） Patients only receive B-ACT therapy. Cell treatment group Bronchial basal cells (BBCs) Patients receive both autologous BBCs transplantation and B-ACT therapy.
- Primary Outcome Measures
Name Time Method Diffusing capacity of the lung for carbon monoxide (DLCO) Week 4, 12, and 24 after treatment An indicator of pulmonary function
- Secondary Outcome Measures
Name Time Method Forced vital capacity (FVC) Week 4, 12, and 24 after treatment An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation
Maximum Voluntary Ventilation (MVV) Week 4, 12, and 24 after treatment An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute
6 minute walk distance (6MWD) and distance saturation product (DSP) Week 4, 12, and 24 after treatment An indicator for heart and pulmonary function
High resolution computed tomography (HR-CT) imaging of lung Week 4, 12, and 24 after treatment An indicator for analysis of dilated bronchi, HR-CT images of lung will be analyzed to indicate the pulmonary structure
Forced expiratory volume measured at the first second (FEV1) Week 4, 12, and 24 after treatment An indicator for pulmonary function test to assess airway obstruction
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 An indicator in pulmonary function test to represent the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity
Maximum Mid Expiratory Flow (MMEF) Week 4, 12, and 24 after treatment An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second
St. George's Respiratory Questionnaire (SGRQ) Week 4, 12, and 24 after treatment An indicator to measure health status (quality of life) in patients with diseases of airways obstruction
FACED scoring Week 4, 12, and 24 after treatment An assessment of severity tool, validated for people with non-cystic fibrosis bronchiectasis. F means "FEV1", A means "Age", C means "Chronic colonization", E means "Extension", D means "Dyspnoea".
Bronchiectasis Severity Index (BSI) Week 4, 12, and 24 after treatment A combination of clinical, radiological and microbiological features to predict morbidity and mortality.
Safety outcomes: adverse events Through study completion, an average of 24 weeks Any unexpected and unfavorable medical occurrence related to any medical intervention in the study
Trial Locations
- Locations (1)
Ruijin Hospital Shanghai JiaoTong University School of Medicine
🇨🇳Shanghai, Shanghai, China