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| Name | Class |
|---|---|
| Regend Therapeutics | INDUSTRY |
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Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive damage of lung structure and decline in lung function.This study intends to carry out an open, single-center, non-randomized, self control phase I clinical trial. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After 24-week observation, the investigators will evaluate the safety and efficacy of the treatment by measuring the key clinical indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lung stem cells | Experimental | Patients will receive 0.5-5x10^6 (0.5-5 million)/Kg/person cells of clinical grade lung stem cells (LSCs)injected via fiberoptic bronchoscopy after fully lavage of the localized lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung stem cells | Biological | Patients will receive 0.5-5x10^6 (0.5-5 million) /Kg/person cells of clinical grade lung stem cells (LSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of the study was the incidence and severity of the cell therapy-related AEs | To evaluate the safety of the drugs | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complication related to bronchoscopy | 1 week | |
| Evaluation of cell therapy efficacy through DLCO-SB test | 24 weeks | |
| exercise tolerance test (6MWD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200123 | China |
| 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. |
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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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| 24 weeks |
| Life quality: assessed by St. George respiratory questionnaire (SGRQ) | 24 weeks |
| Change from baseline in forced vital capacity (FVC) | FVC indicates the volume of air that can forcibly be blown out after full inspiration. | 24 weeks |
| Change from baseline in imaging of lung by high resolution computed tomography (HR-CT) | Images of lung will be analyzed to indicate the newly-derived pulmonary structure | 24 weeks |
| IPF exacerbation events | 24 weeks |
| Change from baseline in forced expiratory volume in one second (FEV1) | FEV1 is the volume of breath exhaled with effort in one second. | 24 weeks |