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RECRUITING
NCT07355868
EARLY_PHASE1

Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy

Sponsor: Regend Therapeutics

View on ClinicalTrials.gov

Summary

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND007 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. A prospective, single-arm, dose-escalation exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of different doses of REGEND007 cell therapy administered by intravenous infusion in the treatment of COPD, and to recommend appropriate treatment doses for subsequent clinical studies.

Official title: An Exploratory Clinical Study on the Intravenous Infusion of REGEND007 (Generic Airway Basal Layer Stem Cells) for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-03-19

Completion Date

2026-12-15

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

REGEND007

This study's intravenous infusion dose escalation protocol is based on a 3+3 dose escalation design, with a total of 4 dose groups. Each group included 3 subjects, and the dose is gradually increased until the maximum tolerated dose (MTD) or the maximum administered dose (MAD) is reached.

Locations (1)

The Fourth Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China