REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
Ruijin Hospital
10 participants
Jun 30, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Age 40-75 years.
- Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
- DLCO ≥30% and <80% predicted.
Exclusion Criteria3
- Pregnancy, lactation, or plans for pregnancy within 1 year.
- Active malignancy or history of malignancy.
- Positive serology for HIV, HBV, HCV, or syphilis.
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06998706