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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Transplantation of autologous bronchial basal cells
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing Municipality, China
Indicators for safety
Measured by blood routine test, urine routine test and blood chemistry panels
Time frame: 1-6 months
Diffusion capacity of CO (DLCO)
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
Time frame: 1-6 months
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
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
Time frame: 1-6 months
Maximum mid-expiratory flow (MMF)
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
Time frame: 1-6 months
Maximum voluntary ventilation (MVV)
One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
Time frame: 1-6 months
Forced expiratory volume in one second (FEV1)
One of the indicators in pulmonary function test, a marker to assess airway obstruction
Time frame: 1-6 months
6-minute-walk test (6MWT)
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Time frame: 1-6 months
Modified medical research council (MMRC) chronic dyspnea scale
An indicator to evaluate the level of dyspnea
Time frame: 1-6 months
St. George's respiratory questionnaire (SGRQ) scale
A questionnaire to assess life quality affected by the respiratory problems
Time frame: 1-6 months
Imaging of lung by high resolution computed tomography (HR-CT)
HR-CT images of lung will be analyzed to indicate the pulmonary structure.
Time frame: 1-6 months
Forced vital capacity (FVC)
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
Time frame: 1-6 months
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