NCT06998706

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Lung Disease (ILD)

Interventions

Type	Name	Description
BIOLOGICAL	REGEND001 Autologous Basal Layer Stem Cell Suspension	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.

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-05-31
• Last updated: 2025-05-31