REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 40-75 years.
• Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
• DLCO ≥30% and \<80% predicted.
Locations
Other Locations
China
Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine
RECRUITING
Qionghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 10
Treatments
Experimental: ICD patients
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital