This study is a prospective, single-arm, dose-escalation exploratory clinical trial to investigate the safety, tolerability and preliminary efficacy of REGEND007 stem cell preparation administered by intravenous infusion in the treatment of idiopathic pulmonary fibrosis (IPF), with a follow-up period of 12 weeks.
Gender is not restricted. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of the boundary value).
Diagnosed with idiopathic pulmonary fibrosis (IPF).
During the screening process, the six-minute walk test should be ≥ 150 meters and < 600 meters; or the lung function FVC should be > 30% of the predicted value.
Voluntarily sign the informed consent form, be able to cooperate with the completion of research-related procedures and examinations, and be able to comprehensively describe or record the changes in the condition.
Female subjects who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male subjects whose partner is planning to become pregnant.
Subjects selected during the screening whose estimated survival period is less than one year.
Subjects selected during the screening who have a current or past history of malignant tumors (excluding malignant tumors with a disease-free survival of more than five years and judged by the researcher to have a relatively mild invasiveness, such as non-melanoma skin cancer, invasive cervical cancer, bladder cancer, thyroid cancer, and breast cancer, etc.).
Subjects selected within 4 weeks before diagnosis of pneumonia (including bacterial, fungal or viral pneumonia).