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Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy

NCT05638776 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-07-31

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. REGEND001 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, single-blind, placebo-parallel-controlled trial is performed to assess the efficacy and safety of REGEND001 cell therapy in treatment of chronic obstructive pulmonary disease with diffusion capacity defect.

Conditions

Interventions

DRUG

REGEND001 cell therapy

Transplantation of the cell product

DRUG

Placebo

Transplantation of Placebo

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Southwest Hospital, China

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • Regend Therapeutics XLotus (Jiangxi) Co, Ltd.

    collaborator UNKNOWN

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Regend Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2025-07-09
Completion
2025-07-09

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05638776 on ClinicalTrials.gov