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.
Age 25-80 years.
Confirmed diagnosis of bronchiectasis.
FEV1 ≥35% predicted; DLCO ≥30% and <80% predicted.
Pregnancy, lactation, or plans for pregnancy within 1 year.
Active malignancy or history of malignancy.
Positive serology for HIV, HBV, HCV, or syphilis.
Single group
REGEND001 Autologous Basal Layer Stem Cell Suspension
Biological/VaccineREGEND001 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.
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.
Change in FEV1 from baseline
The forced expiratory volume in 1s (FEV1) is a measurement of the airflow capacity.
Incidence of adverse events and serious adverse events.
Change in HRCT lung imaging scores
HRCT, high-resolution computed tomography.
Quality of life (QoL) assessment via validated questionnaires
Score range: 0 to 100. Higher scores indicate a worse outcome.
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