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

NCT07828353 | Not Yet Recruiting Phase 3

• 1 other identifier: REGEND001-COPD-251
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

airway basal stem cells; regenerative medicine; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change from baseline in COPD Assessment Test (CAT) score

  Week 12, 24 and 52 after treatment

• Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score

  Week 12, 24 and 52 after treatment

• Change from baseline in DLCO

  Week 12, 24 and 52 after treatment

• Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO

  Week 12, 24 and 52 after treatment

• Change from baseline in alveolar volume (VA)

  Week 12, 24 and 52 after treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.

Biological: Placebo

REGEND001

EXPERIMENTAL

Participants randomized to the experimental arm will receive a single administration of REGEND001.

Biological: REGEND001

Interventions

Placebo BIOLOGICAL

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.

Placebo

REGEND001 BIOLOGICAL

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.

REGEND001

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Regend Therapeutics: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shiyue Li, Professor and Chief Physician

CONTACT

86-20-83062114; lishiyue@188.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)