Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

Study Overview
=================
Brief Summary
-----------------
Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, expanded cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Official Title
-----------------
A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Biological: Bronchial basal cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 40 to 75; Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.); Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year; Tolerant to bronchofiberscope; Written informed consent signed. Exclusion Criteria: Pregnant or lactating women; Patients positive for syphilis, HIV; Patients with malignant tumor; Patients with serious significant pulmonary infection and need anti-infection treatment; Patients with serious heart disease(NYHA class Ⅲ-Ⅳ); Patients with a history of abusing alcohol and illicit drug; Patients participated in other clinical trials in the past 3 months; Patients assessed as inappropriate to participate in this clinical trial by investigator.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchial basal cells<br>Transplantation of autologous bronchial basal cells | Biological: Bronchial basal cells<br>* Transplantation of autologous bronchial basal cells<br>|
| No Intervention: Control<br>Conventional treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indicators for safety | Measured by blood routine test, urine routine test and blood chemistry panels | 1-6 months | 
| Diffusion capacity of CO (DLCO) | One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood | 1-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) | One of the indicators in pulmonary function test, representing 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 | 1-6 months | 
| Maximum mid-expiratory flow (MMF) | One of the indicators in pulmonary function test, standing for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second | 1-6 months | 
| Maximum voluntary ventilation (MVV) | One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute | 1-6 months | 
| Forced expiratory volume in one second (FEV1) | One of the indicators in pulmonary function test, a marker to assess airway obstruction | 1-6 months | 
| 6-minute-walk test (6MWT) | An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases | 1-6 months | 
| Modified medical research council (MMRC) chronic dyspnea scale | An indicator to evaluate the level of dyspnea | 1-6 months | 
| St. George's respiratory questionnaire (SGRQ) scale | A questionnaire to assess life quality affected by the respiratory problems | 1-6 months | 
| Imaging of lung by high resolution computed tomography (HR-CT) | HR-CT images of lung will be analyzed to indicate the pulmonary structure. | 1-6 months | 
| Forced vital capacity (FVC) | One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation | 1-6 months |