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COPD Treatment by Transplantation of Autologous Bronchial Basal Cells

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Autologuos transplantation of bronchial basal cells

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, cell therapy, bronchial basal cells, autologous transplantation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bronchial basal cells

Control

Arm Description

Treatment by autologous bronchial basal cells.

No interventon.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Forced expiratory volume in one second (FEV1)

It indicates the volume of air that can forcibly be blown out in first second, after full inspiration.

Forced vital capacity (FVC)

It indicates the volume of air that can forcibly be blown out after full inspiration.

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

It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity

Maximum voluntary ventilation (MVV)

It indicates the maximum amount of air that can be inhaled and exhaled within one minute

6-minute-walk test (6MWT)

An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases.

Imaging of lung structure by computed tomography (CT)

Images of lung will be analyzed to indicate the newly-derived pulmonary structure.

Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale

Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.

Chronic obstructive pulmonary disease assessment test (CAT)

A patient-completed questionnaire assessing all aspects of the impact of Chronic obstructive pulmonary disease. Higher scores represent a worse outcome.

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

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

Full Information

NCT ID

NCT05594303

First Posted

March 26, 2019

Last Updated

September 18, 2023

Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Regend Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05594303

Brief Title

COPD Treatment by Transplantation of Autologous Bronchial Basal Cells

Official Title

Research on Chronic Obstructive Pulmonary Disease (COPD) Treatment by Transplantation of Autologous Bronchial Basal Cells

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

November 27, 2019 (Actual)

Primary Completion Date

May 16, 2022 (Actual)

Study Completion Date

November 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Regend Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, cell therapy, bronchial basal cells, autologous transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bronchial basal cells

Arm Type

Experimental

Arm Description

Treatment by autologous bronchial basal cells.

Arm Title

Control

Arm Type

No Intervention

Arm Description

No interventon.

Intervention Type

Biological

Intervention Name(s)

Autologuos transplantation of bronchial basal cells

Intervention Description

Autologuos transplantation of bronchial basal cells

Primary Outcome Measure Information:

Title

Diffusing capacity of the lung for carbon monoxide (DLCO)

Description

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

Time Frame

Change from baseline DLCO at 3 months after transplantation

Secondary Outcome Measure Information:

Title

Forced expiratory volume in one second (FEV1)

Description

It indicates the volume of air that can forcibly be blown out in first second, after full inspiration.

Time Frame