A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a common, progressive, and heterogeneous respiratory disorder. It is associated with substantial morbidity and mortality worldwide, leading to progressive decline in lung function, impaired quality of life, and a significant healthcare burden. REGEND001, made from airway basal stem cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, blinded, placebo-parallel-controlled trial is performed to verify the efficacy and safety of REGEND001 in treatment of COPD patients with emphysema.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Biological: Placebo; Biological: REGEND001

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shiyue Li, Professor and Chief Physician; Phone Number: 86-20-83062114; Email: lishiyue@188.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged 40-75 years；
• Diagnosed with COPD;
• Post-bronchodilator FEV1/FVC <0.7
• Emphysematous lesions demonstrated by HRCT;
• Hemoglobin-corrected DLCO%predicted ≥20% and <70%;
• Post-bronchodilator FEV1%predicted ≤80%;
• COPD Assessment Test (CAT) score ≥3;

Exclusion Criteria:

• History of ≥2 COPD exacerbations leading to hospitalization within 1 year prior to screening, or a COPD exacerbation leading to hospitalization within 2 months prior to screening;
• Current or previous history of malignancy;
• An assessed life expectancy of <1 year;
• Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening;
• History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening;
• Diagnosis of pneumonia within 3 months prior to screening;
• Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening;
• Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet therapy, who are unable to discontinue such medications for at least 1 week prior to cell collection and cell infusion;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.	Biological: Placebo; Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of placebo via bronchoscopy and 1 year of follow-up.
Experimental: REGEND001; Participants randomized to the experimental arm will receive a single administration of REGEND001.	Biological: REGEND001; Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of REGEND001 via bronchoscopy and 1 year of follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）	The change from baseline in measured DLCO is defined as the difference between the absolute measured DLCO value at baseline and that measured at the assessment time point after treatment.	Week 52 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in COPD Assessment Test (CAT) score	The change from baseline in CAT score is defined as the difference between the CAT score at baseline and the CAT score measured at the specified post-treatment assessment time point.	Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score	Minimal clinically important difference for CAT is recognized as 2 points.	Week 12, 24 and 52 after treatment
Change from baseline in DLCO	DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).	Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO	Minimal clinically important difference (MCID) of DLCO is recognized as 11%.	Week 12, 24 and 52 after treatment
Change from baseline in alveolar volume (VA)	VA is assessed by measured values, measured/predicted ratio and corresponding area under curve (AUC).	Week 12, 24 and 52 after treatment
Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator	FEV1 is assessed by measured value, measured/predicted ratio and corresponding area under curve (AUC).	Week 12, 24 and 52 after treatment
Change from baseline in 6-minute walk distance (6MWD)	6MWD is assessed by the measured value and corresponding area under curve	Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥30-meter change from baseline in 6MWD	Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.	Week 12, 24 and 52 after treatment
Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score	The St. George's Respiratory Questionnaire for COPD (SGRQ-C) is a validated disease-specific patient-reported outcome measure used to assess the impact of COPD on patients' health status and quality of life. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.	Week 12, 24 and 52 after treatment
Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score	Minimal clinically important difference for SGRQ is recognized as 4 points.	Week 12, 24 and 52 after treatment
Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics	The annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics, represents the adjusted frequency of acute exacerbations of COPD over the assessment period.	Week 52 after treatment
Change from baseline in arterial blood gas parameters	The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.	Week 52 after treatment
Change from baseline in HRCT images	HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).	Week 52 after treatment
Adverse Event	An adverse event (AE) is any untoward medical occurrence in a subject who has received a study intervention, regardless of whether or not it is considered related to the intervention.	Hour 24, Week 12, 24 and 52 after treatment

Collaborators and Investigators

• Sponsor: Regend Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: COPD; regenerative medicine; airway basal stem cells
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: REGEND001-COPD-251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No