COPD Treatment by Transplantation of Autologous Bronchial Basal Cells

NCT ID: NCT05594303

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2022-11-18

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a group of disease characterized by obstructed airflow. Usually, the lung structure is gradually impaired along with the progression of the disease. Recently, the treatment of disease is challenged by shortage of approaches for regenerating the injured lung tissue. Here in this study, investigators intend to perform a single-centered, open, concurrent-controlled phase I/II clinical trial with autologous bronchial basal cells on COPD treatment since they were proved to regenerate lung tissue in animal models. The participants is recruited and divided into experiment group and control group. For patients from experiment group, bronchial basal cells will be isolated, expanded, carefully characterized in vitro and transplanted autologously into lung by fiberoptic bronchoscopy. No intervention is performed for patients from control group. During the study, the safety and efficacy will be evaluated on all the subjects by measuring the key indicators.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bronchial basal cells

Treatment by autologous bronchial basal cells.

Group Type: EXPERIMENTAL

Autologuos transplantation of bronchial basal cells

Intervention Type: BIOLOGICAL

Autologuos transplantation of bronchial basal cells

Control

No interventon.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Autologuos transplantation of bronchial basal cells

Autologuos transplantation of bronchial basal cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects aged between 40 to 75;
• Subjects diagnosed with COPD and meet the following standards: a. sustained airway obstruction; b. post-bronchodilator FEV1<80% predicted value;
• Subjects with DLCO<80% predicted value in spirometry;
• Subjects with a smoking history more than 10 pack-years (current smoker and former smoker);
• 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 requiring anti-infection (bacteria or virus) treatment by intravenous drugs;
• Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension caused by other diseases;
• Subjects with a history of invasive or non-invasive mechanical ventilation in the past 4 weeks;
• 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 allergic to products from cattle and pig;
• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regend Therapeutics

INDUSTRY

Sponsor Role: collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

ShiYue Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiyue Li

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Locations

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2018001

Identifier Type: -

Identifier Source: org_study_id