Follow-up Study of Autologous Transplantation of P63+ Lung Progenitor Cells for Treatment of Bronchiectasis

Subjects once received cell treatment

Inclusion criteria

• Subjects diagnosed as bronchiectasis.
• Subjects have participated in the clinical trial of autologous transplantation of P63+ LPCs for treatment of bronchiectasis, and actually received LPCs transplantation treatment.
• Subjects with stable condition for more than 2 weeks.
• Subjects can tolerate bronchoscopy.
• Subjects signed informed consent.
• Subjects with good compliance.

Exclusion criteria

• 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 chronic obstructive pulmonary disease (COPD).
• Subjects with 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: alanine transaminase (ALT), aspartate transaminase (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.

Subjects providing samples of surgically resected bronchiectasis lesions

Inclusion criteria

• Subjects diagnosed as bronchiectasis.
• Subjects have never participated in the clinical trial of autologous transplantation of P63+ LPCs for treatment of bronchiectasis, and never received LPCs transplantation treatment.
• Subjects have once received surgery to remove bronchiectasis lesions and lung samples are still kept in the Department of Pathology, Ruijin Hospital till now.
• Subjects signed informed consent.

Exclusion criteria

• 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 a history of alcohol or illicit drug abuse.
• Subjects accepted by any other clinical trials within 3 months before the enrollment.