Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis

Inclusion criteria

• Male or female, aged between 50 to 75;
• Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2018 edition;
• Subjects with 30%~79% of the predicted value in diffusing capacity for carbon monoxide (DLCO) in pulmonary function tests 3 months before screening;
• Subjects with typical High-resolution computed tomography (HR-CT) imaging findings of idiopathic pulmonary fibrosis in the past 12 months;
• Subjects tolerant to bronchofiberscope;
• Subjects fully informed of the purpose, method and possible discomfort of the trial, agreeing to participate in the test, and voluntarily signing the informed consent;
• Subjects with good adherence, willingness to take medication and regular follow-up examinations as required by the protocol;
• Subjects able to understand and cooperate with the completion of pulmonary function tests.

Exclusion criteria

• Subjects who cannot tolerate cell therapy;
• Pregnant or lactating women;
• Subjects with syphilis or any of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) positive antibody; Of which stable HBV carriers after drug treatment (DNA titer ≤500 IU/mL or copy number <1000 copies/mL) and cured hepatitis C patients (HCV RNA is negative) can be enrolled;
• Subjects with malignant tumors or a history of malignant tumors;
• Subjects with serious significant pulmonary infection and needing anti-infection treatment;
• Subjects with taking drugs which caused lung fibroblast such as amiodarone in a long term before screening;
• Subjects with infections in lung or other site, including bacterial and viral infections, requiring intravenous treatment before cell transplantation;
• Subjects with a history of invasive or noninvasive mechanical ventilation within 4 weeks;
• Subjects with any of the following lung diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, pneumoconiosis, etc.; lung cancer, bronchiolitis obliterans or other active lung disease; Pneumonia currently or within the last 4 weeks; Pneumonectomy Previously;
• Subjects needing oxygen therapy currently (oxygen therapy time> 15h/d);
• Subjects suffering from serious other systemic diseases, such as myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, connective tissue disease, etc.;
• Subjects with following results : leukopenia (leukopenia < 4×10^9/L) or agranulocytosis (leukocyte < 1.5×10^9/L or neutrophils < 0.5×10^9/L) of any cause; Blood creatinine > 2.5 times the upper limit of normal; Alanine transaminase (ALT) and Aspartate transaminase (AST) > 2.5 times the upper limit of normal values in the laboratory tests;
• Subjects with a history of mental illness or suicide risk, epilepsy or other central nervous system disorders;
• Subjects with severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG);
• Subjects with a history of abusing alcohol and illicit drug;
• Subjects with serious heart disease [New York Heart Association (NYHA) class III-IV];
• Subjects who are allergic to cattle products;
• Subjects who participated in other clinical trials in the past 3 months;
• Subjects with poor compliance and difficult to complete the investigation;
• Investigators, employees of research centers or family members of them (none of whom are suitable to participate in the trial to ensure the objectivity of the research);
• Subjects who had an acute exacerbation of IPF or hospitalized for other respiratory diseases 3 or more times in the past 1 year;
• Subjects who take nintedanib for medication within 1 month, or plan to continue taking nintedanib for medication;
• Subjects with other acquired or congenital immunodeficiency disorders, or with a history of organ transplantation or cell transplant therapy;
• Subjects whose expected survival may be less than one year judged by the investigator;
• Male participants of childbearing potential and female participants within childbearing age were reluctant to use effective contraception from the time of signing the informed consent to 6 months after cell therapy;
• Subjects assessed as inappropriate to participate in this clinical trial by investigator.