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This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGEND001 Autologous Basal Layer Stem Cell Suspension | Biological | REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DLCO from baseline. | The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung. | Baseline, 4 weeks post treatment, 24 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FVC from baseline | The forced vital capacity (FVC) is a measurement of the airflow capacity. | Baseline, 4 weeks post treatment, 24 weeks post treatment |
| Incidence of adverse events and serious adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Through study completion, an average of 6 months |
| High-resolution CT (HRCT) imaging scores | Baseline, 4 weeks post treatment, 24 weeks post treatment |
| Quality of life (QoL) assessment via validated respiratory questionnaires | Score range: 0 to 100. Higher scores indicate a worse outcome | Baseline, 4 weeks post treatment, 24 weeks post treatment |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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