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

NCT07355868 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

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.

Sponsors & Collaborators

  • Regend Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-10-15
Completion
2026-12-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355868 on ClinicalTrials.gov