RecruitingEarly Phase 1NCT07355868

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

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


Sponsor

Regend Therapeutics

Enrollment

12 participants

Start Date

Mar 19, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called REGEND007 for people with chronic obstructive pulmonary disease (copd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALREGEND007

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

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NCT07355868


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