Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Nanfang Hospital, Southern Medical University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Biological: Bronchial basal cell

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03092648

NFEC-2016-187

Details and patient eligibility

About

Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial 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, cultured 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.

Enrollment

20 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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 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.