Autologous Transplantation of Bronchial Basal Cells for Treatment of COPD

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 1

Conditions

COPD

Treatments

Biological: Bronchial basal cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03655795

201809

Details and patient eligibility

About

Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from 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 lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, the CT imaging, 6 minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale and COPD assessment test (CAT).

Enrollment

20 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects aged between 40 to 75.
Subjects diagnosed with COPD and meet the following standards: a.sustained airway obstruction; b.presence of persistent airflow limitation confirmed by post-bronchodilator FEV1<70% predicted value and FEV1/FVC < 0.7.
Subjects with pulmonary emphysema confirmed by imaging evidence.
Subjects with DLCO<80% predicted value in pulmonary function test.
Subjects with stable condition for more than 4 weeks.
Subjects tolerant to bronchoscopy.
Subjects signed informed consent.

Exclusion criteria

Pregnant or lactating women.
Subjects with syphilis or any of HIV, HBV, HCV positive antibody.
Subjects with any malignancy.
Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension or interstitial lung disease.
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 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.