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COMPLETED
NCT05638776
PHASE2

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

Official title: A Multicenter, Randomized, Single-Blind, Placebo-Parallel-Controlled Research of REGEND001 Cell Therapy for Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2022-12-06

Completion Date

2025-07-09

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DRUG

REGEND001 cell therapy

Transplantation of the cell product

DRUG

Placebo

Transplantation of Placebo

Locations (8)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The Southwest Hospital of AMU

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China