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This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchiectasis 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 FEV1 from baseline | The forced expiratory volume in 1s (FEV1) 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 |
| Change in HRCT lung imaging scores | HRCT, high-resolution computed tomography. | Baseline, 4 weeks post treatment, 24 weeks post treatment |
| Quality of life (QoL) assessment via validated questionnaires | Score range: 0 to 100. Higher scores indicate a worse outcome. | Baseline, 4 weeks post treatment, 24 weeks post treatment |