REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study

REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study

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.

Inclusion Criteria:

1. Age 40-75 years.
2. Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
3. DLCO ≥30% and <80% predicted.

Exclusion Criteria:

1. Pregnancy, lactation, or plans for pregnancy within 1 year.
2. Active malignancy or history of malignancy.
3. Positive serology for HIV, HBV, HCV, or syphilis.