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| Name | Class |
|---|---|
| Regend Therapeutics | INDUSTRY |
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Chronic obstructive pulmonary disease (COPD) is a group of disease characterized by obstructed airflow. Usually, the lung structure is gradually impaired along with the progression of the disease. Recently, the treatment of disease is challenged by shortage of approaches for regenerating the injured lung tissue. Here in this study, investigators intend to perform a single-centered, open, concurrent-controlled phase I/II clinical trial with autologous bronchial basal cells on COPD treatment since they were proved to regenerate lung tissue in animal models. The participants is recruited and divided into experiment group and control group. For patients from experiment group, bronchial basal cells will be isolated, expanded, carefully characterized in vitro and transplanted autologously into lung by fiberoptic bronchoscopy. No intervention is performed for patients from control group. During the study, the safety and efficacy will be evaluated on all the subjects by measuring the key indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial basal cells | Experimental | Treatment by autologous bronchial basal cells. |
|
| Control | No Intervention | No interventon. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologuos transplantation of bronchial basal cells | Biological | Autologuos transplantation of bronchial basal cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diffusing capacity of the lung for carbon monoxide (DLCO) | It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood | Change from baseline DLCO at 3 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | It indicates the volume of air that can forcibly be blown out in first second, after full inspiration. | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| Forced vital capacity (FVC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyue Li | Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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It indicates the volume of air that can forcibly be blown out after full inspiration. |
| Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) | It represents 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 | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| Maximum voluntary ventilation (MVV) | It indicates the maximum amount of air that can be inhaled and exhaled within one minute | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| 6-minute-walk test (6MWT) | An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases. | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| Imaging of lung structure by computed tomography (CT) | Images of lung will be analyzed to indicate the newly-derived pulmonary structure. | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale | Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome. | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| Chronic obstructive pulmonary disease assessment test (CAT) | A patient-completed questionnaire assessing all aspects of the impact of Chronic obstructive pulmonary disease. Higher scores represent a worse outcome. | Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation |
| Diffusing capacity of the lung for carbon monoxide (DLCO) | It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood | Change from baseline DLCO at 6 months after transplantation |
| Diffusing capacity of the lung for carbon monoxide (DLCO) | It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood | Change from baseline DLCO at 12 months after transplantation |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |