Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Interventions
BIOLOGICALBronchial basal cell
autologous bronchial basal cell transplantation
Sponsors
Regend Therapeutics
Tongji University
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open, non-random, concurrent control
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | 1-6 months | One of the indicators for pulmonary function |
| Forced vital capacity (FVC) | 1-6 months | One of the indicators for pulmonary function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1/FVC, MMF, MVV and DLCO | 1-6 months | Other indicators for the pulmonary function |
| 6 minute walk test (6MWT) | 1-6 months | Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases |
| MMRC | 1-6 months | Indicator to evaluate the level of dyspnea |
| SGRQ | 1-6 months | A questionnaire to assess life quality affected by the respiratory problems |
Countries
China
Contacts
Primary ContactGuodong Hu, M.D.
Backup ContactWei Zuo, Ph. D.
Outcome results
None listed