Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001

Launched by REGEND THERAPEUTICS · Dec 19, 2022

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Eligibility criteria

• Inclusion Criteria:
• • Male or female, aged between 50 to 75.
• • Diagnosis of IPF according to 2018 Idiopathic Pulmonary Fibrosis Diagnostic Guidelines.
• • Participants with 30%\~79% of the predicted value in diffusing capacity for carbon monoxide (DLCO) and more than 50% of the predicted value in forced vital capacity (FVC) in pulmonary function tests within 3 months before screening.
• • Participants with typical HRCT images of IPF in the past 12 months.
• • Participants tolerant to bronchofiberscopy.
• • Participants fully informed with the purpose, method and possible discomfort of the trial, agreeing to participate in the trial and signing the informed consent voluntarily.
• • Participants with good adherence, willing to take medication and regular follow-up examinations as required by the protocol.
• • Participants able to understand and cooperate with the completion of pulmonary function tests.
• Exclusion Criteria:
• • Participants who cannot tolerate cell therapy.
• • Pregnant or lactating women.
• • Participants 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 and cured hepatitis C patients can be enrolled.
• • Participants with malignant tumors or a history of malignant tumors.
• • Participants with a history of long-term use of drugs known to cause pulmonary fibrosis, such as amiodarone before screening.
• • Participants with lung infections or other infections, including bacterial and viral infections, with requirement of intravenous medications before cell transplantation.
• • Participants with a history of invasive or noninvasive mechanical ventilation within 4 weeks.
• • Participants 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 in the past 4 weeks; pneumonectomy previously.
• • Requirement of oxygen therapy for more than 15 hours per day.
• • Suffering from serious diseases of other system.
• • leukopenia or agranulocytosis 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 in the laboratory tests.
• • Participants with a history of mental illness, suicide risk, epilepsy or other central nervous system disorders.
• • 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).
• • Participants with a history of abusing alcohol or illicit drug.
• • Participants allergic to cattle products.
• • Participants in other clinical trials in the past 3 months.
• • Participants with poor compliance and difficult to complete the trial.
• • 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);
• • Participants with a history of hospitalization owing to acute exacerbation of IPF or other respiratory diseases three or more times within the past year.
• • Participants who is taking or is goning to take nintedanib within a month.
• • Participants with other acquired or congenital immunodeficiency disorders, or with a history of organ transplantation or cell transplantation therapy.
• • Participants 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.
• • Participants assessed to be inappropriate in this clinical trial by investigator.