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| Name | Class |
|---|---|
| Regend Therapeutics | INDUSTRY |
| Tongji University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial basal cells | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial basal cell | Biological | autologous bronchial basal cell transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | One of the indicators for pulmonary function | 1-6 months |
| Forced vital capacity (FVC) | One of the indicators for pulmonary function | 1-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1/FVC, MMF, MVV and DLCO | Other indicators for the pulmonary function | 1-6 months |
| 6 minute walk test (6MWT) | Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guodong Hu, M.D. | Contact | huguodong123123@126.com | ||
| Wei Zuo, Ph. D. | Contact | zuow@regend.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zuo, Ph. D. | Regend Therapeutics Co.Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 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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open, non-random, concurrent control
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| 1-6 months |
| MMRC | Indicator to evaluate the level of dyspnea | 1-6 months |
| SGRQ | A questionnaire to assess life quality affected by the respiratory problems | 1-6 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |