COPD Treatment by Transplantation of Autologous Bronchial Basal Cells

NCT05594303 | Completed Phase 1

• 1 other identifier: 2018001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Keywords

COPD; cell therapy; bronchial basal cells; autologous transplantation

Outcome Measures

Primary Outcomes (1)

• Diffusing capacity of the lung for carbon monoxide (DLCO)

  It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood

  Change from baseline DLCO at 3 months after transplantation

Secondary Outcomes (10)

• Forced expiratory volume in one second (FEV1)

  Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

• Forced vital capacity (FVC)

  Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

• The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC)

  Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

• Maximum voluntary ventilation (MVV)

  Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

• 6-minute-walk test (6MWT)

  Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

Study Arms (2)

Bronchial basal cells

EXPERIMENTAL

Treatment by autologous bronchial basal cells.

Biological: Autologuos transplantation of bronchial basal cells

Control

NO INTERVENTION

No interventon.

Interventions

Autologuos transplantation of bronchial basal cells BIOLOGICAL

Autologuos transplantation of bronchial basal cells

Bronchial basal cells

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Regend Therapeutics: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiyue Li

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: October 26, 2022
• Study Start: November 27, 2019
• Primary Completion: May 16, 2022
• Study Completion: November 18, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)