Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy

Exclusion Criteria

• •Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
• •Subject positive in each of the tests containing treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at screening. But except the followings:
• •1. Hepatitis B virus carriers (only HBsAg positive without any hepatitis symptom or sign, and all liver function tests present normal results or abnormal markers without clinical significance by the assessment of investigators);
• •2. Cured hepatitis C patients (negative in HCV ribonucleic acid (RNA) test);
• •Subject with assessed survival time of \< 1 year by investigators at screening;
• •Subject with malignant tumors or a history of malignant tumors at screening;
• •Subject with infections in lung or other sites, requiring intravenous drug treatment within a week prior to screening;
• •Subject with more than 4 moderate-to-severe AECOPD, resulting in hospitalization within a year prior to screening;
• •Subject with one or more pathogenetic or serologic findings of the novel coronavirus infection, or symptoms of suspected infection within 6 weeks prior to screening;
• •Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks prior to screening;
• •Subject who has taken prednisone tablets orally at a dose of ≥ 20 mg/day (or equivalent amount of other oral corticosteroids) within 4 weeks prior to screening;
• •Subject with major lung diseases other than COPD by assessment of investigators at screening;
• •Subject with severe systemic diseases other than lung within 6 months prior to screening and assessed to be inappropriate to participate in this trial by investigators;
• •Subject with severe anemia or poorly controlled granulocyte deficiency, thrombocytopenia by assessment of investigators;
• •Subject with abnormal coagulation and assessed to be negative for the safety of fiberoptic bronchoscopy operations at screening;
• •Subject requiring long-term anticoagulation therapy of using antiplatelet coagulant therapeutic agents and disable to discontinue their medications 1 week prior to cell collection and cell infusion as assessed by investigators;
• •Subject with a risk of suicide, a history of mental illness or a history of epilepsy at screening;
• •Subject with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
• •Subject participated in other clinical trials with interventions within 3 months prior to screening;
• •Investigators, co-investigators, research coordinators, employees of research participants or research centers, or their family members;
• •Any circumstance considered to probably increase the risk of patients or interfere with the clinical trial.