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NOT YET RECRUITING
NCT06987214
PHASE1

REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

25 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-06-30

Completion Date

2026-05-30

Last Updated

2025-05-23

Healthy Volunteers

No

Interventions

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.