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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| RenJi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Second Affiliated Hospital of Xiamen Medical College |
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Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGEND001 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGEND001 | Biological | REGEND001: 1-1.5×10^6 bronchial basal cells/kg administrated by bronchoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the area under the curve (AUC) of DLCO measured values at each visit from baseline to week 24 between the REGEND001 group and the placebo group. | DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline. | 12 and 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lung diffusing capacity | DLCO will be used to evaluate the lung diffusing capacity. DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It's a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream. | 12 and 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lung ventilatory capacity | Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be used to evaluate the lung ventilatory capacity. FVC indicates the volume of air that can forcibly be blown out after full inspiration. FEV1 is the volume of breath exhaled with effort in one second. | 12 and 24 weeks after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China | |||
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
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| Placebo | Biological | Placebo: Sodium chloride injection administrated by bronchoscopy. |
|
| Progression-free survival (PFS) | PFS refers to the time from randomization or initiation of treatment to the occurrence of disease progression or death. | Within 24 weeks after treatment |
| Change from baseline in 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. | 12 and 24 weeks after treatment |
| Change from baseline in 6-minute-walk test (6MWT) | The 6MWT is a commonly used test for the objective assessment of functional exercise capacity by testing the distance patients can walk at the fastest speed within 6 minutes. | 12 and 24 weeks after treatment |
| Time from enrollment to all-cause death | Time from enrollment to all-cause death is used to evaluate the overall survival of the population. | up to 24 weeks(first period), 5 years (second period). |
| Blood oxygen saturation | Blood oxygen saturation is the measure of how much oxygen is traveling through body in red blood cells. | 12 and 24 weeks after treatment |
| Change from baseline in images of lung by high resolution computed tomography (HR-CT) | HR-CT images of lung will be analyzed to indicate the change of pulmonary structure. | 12 and 24 weeks after treatment |
| Change from baseline in C-reactive protein (CRP) | The level of CRP increases when there's inflammation in the body. | 12 and 24 weeks after treatment |
| Time to acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) | AE-IPF is an often deadly complication of IPF, which is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality. | Within 24 weeks after treatment |
| Temperature | Number of cases with abnormal body temperature. | Within 24 weeks after treatment |
| Breathing | Number of cases with abnormal breathing. | Within 24 weeks after treatment |
| Pulse | Number of cases with abnormal pulse. | Within 24 weeks after treatment |
| Blood pressure | Number of cases with abnormal blood pressure. | Within 24 weeks after treatment |
| Symptoms, physical examination | Number of cases with abnormal physical examination | Within 24 weeks after treatment |
| 12-lead ECG | Number of cases with abnormal 12-lead Electrocardiogram (ECG). | Within 24 weeks after treatment |
| Blood routine | Number of cases with abnormal laboratory test results | Within 24 weeks after treatment |
| Liver & Kidney function check | Number of cases with abnormal results in Liver & Kidney function check | Within 24 weeks after treatment |
| Blood glucose | Number of cases with abnormal results | Within 24 weeks after treatment |
| Function of blood clotting | Number of cases with abnormal function of blood clotting. | Within 24 weeks after treatment |
| Antibody testing for autoimmune diseases | Antibodies related to autoimmune diseases are tested for safety assessment | Within 24 weeks after treatment |
| Carcinoembryonic antigen (CEA) | CEA is a tumor marker used for early diagnosis of lung cancer.Clinically significant changes of this markers will be assessed. | Within 24 weeks after treatment |
| Neuron-specific enolase (NSE) | NSE is a tumor marker significantly elevated in small cell lung cancer. Clinically significant changes of this marker will be assessed | Within 24 weeks after treatment |
| Cytokeratin-19-fragment (CYFRA21-1) | CYFRA21-1 is a tumor marker which is valuable for the pathological classification and prognosis evaluation of lung cancer. Clinically significant changes of this marker will be assessed | Within 24 weeks after treatment |
| Squamous cell carcinoma antigen (SCC) | SCC is a specific marker for lung squamous cell carcinoma. Clinically significant changes of this marker will be assessed | Within 24 weeks after treatment |
| Other cases of adverse effects | Other cases of adverse effects will be recorded and compared. | Within 24 weeks after treatment |
| The Second Affiliated Hospital of Xiamen Medical College |
| Xiamen |
| Fujian |
| 361021 |
| China |
| Ruijin Hospital, Shanghai Jiaotong University School Of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Renji Hospital, Shanghai Jiaotong University School Of Medicine | Shanghai | Shanghai Municipality | 200127 | China |