Autologous Bronchial Basal Cell Transplantation for Treatment of COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Biological: Bronchial basal cells
- Registration Number
- NCT03188627
- Lead Sponsor
- Regend Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bronchial basal cells Bronchial basal cells Transplantation of autologous bronchial basal cells
- Primary Outcome Measures
Name Time Method Indicators for safety 1-6 months Measured by blood routine test, urine routine test and blood chemistry panels
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
- 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
Forced expiratory volume in one second (FEV1) 1-6 months One of the indicators in pulmonary function test, a marker to assess airway obstruction
St. George's respiratory questionnaire (SGRQ) scale 1-6 months A questionnaire to assess life quality affected by the respiratory problems
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
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.
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
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
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
Trial Locations
- Locations (1)
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
🇨🇳Chongqing, Chongqing, China