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| Name | Class |
|---|---|
| Regend Therapeutics | INDUSTRY |
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Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly 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 |
|---|---|---|---|
| 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 into lung via fiberoptic bronchoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung stem cells | Biological | Patients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Increase of diffusing capacity of the lung for carbon monoxide (DLCO) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increase of total lung capacity (TLC) | 24 weeks | |
| Increase in 6 minute walk distance (6MWD) | 24 weeks | |
| Life quality: assessed by St. George respiratory questionnaire (SGRQ) |
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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 |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 24 weeks |