Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regend Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, the CT imaging, 6 minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale and COPD assessment test (CAT).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial basal cells | Experimental | Autologous transplantation of bronchial basal cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial basal cells | Biological | Autologous transplantation of bronchial basal cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diffusing capacity of the lung for carbon monoxide (DLCO) | An indicator for pulmonary function | 6 months -1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume measured at the first second (FEV1) | One of the indicators in pulmonary function test, a marker to assess airway obstruction | 6 months -1 year |
| Forced vital capacity (FVC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieming Qu, M.D., Ph.D | Contact | +86-21-64370045 | jmqu0906@163.com | |
| Wei Zuo, Ph. D | Contact | +86-21-65985082 | zuow@regend.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yun Feng, M.D., Ph.D | Ruijin Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25383540 | Background | Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12. | |
| 29344809 | Background | Ma Q, Ma Y, Dai X, Ren T, Fu Y, Liu W, Han Y, Wu Y, Cheng Y, Zhang T, Zuo W. Regeneration of functional alveoli by adult human SOX9+ airway basal cell transplantation. Protein Cell. 2018 Mar;9(3):267-282. doi: 10.1007/s13238-018-0506-y. Epub 2018 Jan 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
| 6 months -1 year |
| 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 | 6 months -1 year |
| 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 | 6 months -1 year |
| 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 | 6 months -1 year |
| 6-minute-walk test (6MWT) | An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases | 6 months -1 year |
| Imaging of lung structure by high resolution computed tomography (HR-CT) | Images of lung will be analyzed to indicate the newly-derived pulmonary structure. | 6 months -1 year |
| Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale | Total scores (0-100) will be calculated and compared before and after transplantation, and higher values represent a better outcome. | 6 months -1 year |
| Modified medical research council (mMRC) chronic dyspnea scale to evaluate the level of dyspnea | mMRC Dyspnea Scale scores (1-5) will be measured and compared before and after transplantation, and lower values represent a better outcome. | 6 months -1 year |
| COPD Assessment Test (CAT) | A patient-completed questionnaire assessing all aspects of the impact of COPD | 6 months -1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |