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

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;