Clinical trial NCT03156673: Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells
Official title: Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: First Affiliated Hospital of Shantou University Medical College
Sponsor class: OTHER
Collaborators: name: Regend Therapeutics
name: Tongji University
First posted: 2017-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.


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);
* Clinically stable for more than 4 weeks;
* 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 or 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.

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 1-6 months
measure: Forced vital capacity (FVC)
timeFrame: 1-6 months
Secondary outcomes:
measure: Diffusion capacity of CO (DLCO)
timeFrame: 1-6 months
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: 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
Other outcomes:
Locations:
city: Shantou
country: China
facility: the First Affiliated Hospital of Shantou University Medical College
state: Guang Dong
Study officials:
References: