Clinical trial NCT03153800: Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
Official title: Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Respiratory Disease
Lead sponsor: Regend Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2017-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 1-6 months
measure: Diffusion capacity of CO (DLCO)
timeFrame: 1-6 months
Secondary outcomes:
measure: The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
timeFrame: 1-6 months
measure: Maximum mid-expiratory flow (MMF)
timeFrame: 1-6 months
measure: Maximum voluntary ventilation (MVV)
timeFrame: 1-6 months
measure: Forced vital capacity (FVC)
timeFrame: 1-6 months
measure: 6-minute-walk test (6MWT)
timeFrame: 1-6 months
measure: Modified medical research council (MMRC) chronic dyspnea scale
timeFrame: 1-6 months
measure: St. George's respiratory questionnaire (SGRQ) scale
timeFrame: 1-6 months
measure: Imaging of lung by high resolution computed tomography (HR-CT)
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hopsital of Soochow University
state: Jiang Su
Study officials:
References: