Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
- Conditions
- Chronic Respiratory Disease
- Interventions
- Biological: bronchial basal cells
- Registration Number
- NCT03153800
- Lead Sponsor
- Regend Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bronchial basal cells bronchial basal cells -
- Primary Outcome Measures
Name Time Method Diffusion capacity of CO (DLCO) 1-6 months One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
Forced expiratory volume in one second (FEV1) 1-6 months One of the indicators in pulmonary function test, a marker to assess airway obstruction
- Secondary Outcome Measures
Name Time Method Maximum mid-expiratory flow (MMF) 1-6 months 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
Maximum voluntary ventilation (MVV) 1-6 months One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
Forced vital capacity (FVC) 1-6 months 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
Modified medical research council (MMRC) chronic dyspnea scale 1-6 months An indicator to evaluate the level of dyspnea
6-minute-walk test (6MWT) 1-6 months An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
St. George's respiratory questionnaire (SGRQ) scale 1-6 months A questionnaire to assess life quality affected by the respiratory problems
Imaging of lung by high resolution computed tomography (HR-CT) 1-6 months HR-CT images of lung will be analyzed to indicate the pulmonary structure.
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) 1-6 months 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
Trial Locations
- Locations (1)
The First Affiliated Hopsital of Soochow University
🇨🇳Suzhou, Jiang Su, China