Human umbilical cord mesenchymal stem cells(Tianjin Huayu)

Phase 1 (Dose Escalation Study): Primary Objective: To evaluate the safety and tolerability of a single dose of human umbilical cord mesenchymal stem cell injection (HYstem-001) in patients with idiopathic pulmonary fibrosis (IPF), and to recommend appropriate cell therapy doses for subsequent clinical studies. Secondary Objective: To evaluate the efficacy and safety of human umbilical cord mesenchymal stem cell injection (HYstem-001) in patients with IPF. Exploratory Objective: To evaluate the pharmacokinetics, immunogenicity, and biomarker-related characteristics of human umbilical cord mesenchymal stem cell injection (HYstem-001) in patients with IPF. Phase 2 (Dose Expansion Study): Primary Objective: To evaluate the safety of multiple doses of human umbilical cord mesenchymal stem cell injection (HYstem-001) in patients with IPF. Secondary Objective: To evaluate the preliminary efficacy of multiple doses of human umbilical cord mesenchymal stem cell injection (HYstem-001) in patients with IPF. Exploratory objective: To evaluate the pharmacokinetics, immunogenicity, and biomarker-related characteristics of human umbilical cord mesenchymal stem cell injection (HYstem-001) in patients with idiopathic pulmonary fibrosis after multiple administrations.