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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO） — Week 52 after treatment 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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Guangzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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