Status:
COMPLETED
Follow-up Study of Autologous Transplantation of P63+ Lung Progenitor Cells for Treatment of Bronchiectasis
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Regend Therapeutics
Conditions:
Bronchiectasis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is the follow-up study of autologous transplantation of P63+ lung progenitor cells (LPCs) for treatment of bronchiectasis (NCT03655808). Bronchiectasis is the consequence of chronic suppurative i...
Eligibility Criteria
Inclusion
- Subjects once received cell treatment
- 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
- 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.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06164093
Start Date
December 12 2023
End Date
January 31 2024
Last Update
October 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025