A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)

A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy in Idiopathic Pulmonary Fibrosis (IPF) Patients

Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.

Inclusion Criteria:

• Male or female, aged between 40 to 75;
• Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2022 edition;
• Subjects with DLCO (measured/predicted value) ≥30% and <80%, and FVC (measured/predicted value) ≥50% within 3 months prior to screening
• Subjects tolerant to bronchofiberscope;
• Subjects tolerant to test of lung function;
• Subjects able to voluntarily sign the informed consent and cooperate with the completion of pulmonary function tests;

Exclusion Criteria:

• Female subject who is pregnant, nursing, or planning to be pregnant in half a year after using this product (or male subjects planning to have a pregnant spouse);
• At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test, except the following: (1) Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs, all liver function tests are normal); (2) Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test.
• Subject with malignant tumors or a history of malignant tumors;
• Subject with severe anemia, poorly controlled agranulocytosis and thrombocytopenia at screening;
• Subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening;
• Subject with severe arrhythmias or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG);
• Subject who participated in other interventional clinical trials in the past 3 months;
• Subject assessed as inappropriate to participate in this clinical trial by investigators.