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.
Age 40-75 years.
Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
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 FVC from baseline
The forced vital capacity (FVC) is a measurement of the airflow capacity.
Incidence of adverse events and serious adverse events.
High-resolution CT (HRCT) imaging scores
Quality of life (QoL) assessment via validated respiratory questionnaires
Score range: 0 to 100. Higher scores indicate a worse outcome
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