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

Prior treatment

• 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 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 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 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 participated in other clinical trials with interventions within 3 months prior to screening;

Other illness

• Subjects with a positive result for any of the following tests at screening: treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody. But except the followings:
  • 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);
  • Cured hepatitis C patients (negative in HCV ribonucleic acid (RNA) test);
• Subject with malignant tumors or a history of malignant tumors at screening;
• Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks prior to screening;
• Subject with major lung diseases other than COPD by assessment of investigators at screening;
• 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;

Other

• 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 with assessed survival time of \< 1 year by investigators at screening;
• 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;
• 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.

• Male or female, aged 40 to 75 at the time of signing informed consent.
• Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
• The ratio of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)FEV1/FVC is \< 70% after inhalation of bronchodilators.
• The diffusion function of carbon monoxide (DLCO) is ≥ 20% and \< 80% of the predicted value at screening.
• Tolerated to pulmonary function tests.
• Tolerated to bronchoscopy
• Voluntary to sign the informed consent, coordinated to finish the trial-related procedures and tests, and capable of recording or stating the change of disease condition in a relatively complete manner.