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

Launched by RUIJIN HOSPITAL · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial, called REGEND001, is looking at a new treatment for bronchiectasis, which is a chronic lung condition that causes difficulty in breathing due to damaged airways. The trial will test the safety and effectiveness of a therapy that uses the patient’s own stem cells, taken from the lungs, to help repair the damaged lung tissue. In this process, doctors will collect these stem cells, grow them in a lab, and then put them back into the patient's lungs through a procedure called bronchoscopic infusion.

To participate in this trial, patients need to be between the ages of 25 and 80 and have a confirmed diagnosis of bronchiectasis. They should also have certain lung function measurements that meet specific criteria. However, people who are pregnant, have active cancer, or have certain infections cannot join. The trial is not currently recruiting participants, but it offers a promising new approach for those with bronchiectasis to possibly improve their lung health. Participants can expect to be closely monitored throughout the study to ensure their safety and gather important information about how well this treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 25-80 years.
• • 2. Confirmed diagnosis of bronchiectasis.
• • 3. FEV1 ≥35% predicted; 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.