Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF

Study Overview
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Brief Summary
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Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed phase I clinical trial by transplantation of autologous bronchial basal cells on patients suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6 months, the safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Official Title
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Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)

Conditions
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Chronic Respiratory Disease

Intervention / Treatment
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* Biological: bronchial basal cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with COPD, BE or PF according to the guideline; Clinically stable for more than 4 weeks; Tolerant to fiberoptic bronchoscopy test; 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 investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchial basal cells<br> | Biological: bronchial basal cells<br>* Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) | One of the indicators in pulmonary function test, a marker to assess airway obstruction | 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 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 | 
| 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 |