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

Phase 3Not Yet RecruitingNCT07828353

Regend Therapeutics102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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.

Time frame: Week 52 after treatment

Secondary Outcomes

Change from baseline in COPD Assessment Test (CAT) score

The COPD Assessment Test (CAT) is an 8-item questionnaire used to assess the impact of COPD on health status. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD and worse health status. Change from baseline is calculated as the post-treatment CAT score minus the baseline CAT score.