An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Main purpose -To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF). Secondary purpose * To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies. * To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF). This study adopts a clinical research design of multi center, single dose and increasing dose. 18 qualified IPF subjects will be included in this study.
• (1) Age 50\
⁃ 75 years old (including the threshold), regardless of gender;
• (2) IPF was diagnosed according to the diagnostic guidelines for idiopathic pulmonary fibrosis jointly issued by the American Thoracic Society (ATS), the European Respiratory Society (ERs), the Japanese Respiratory Society (JRS) and the Latin American Thoracic Association (ALAT) in 2018;
• (3) Subjects with typical imaging manifestations of IPF (honeycomb, stretch bronchiectasis or bronchiectasis (mainly in ground glass shadow and fine mesh shadow) on HRCT within 12 months before screening;
• (4) Within 3 months before administration, the researcher determined that the disease was stable. The pulmonary carbon monoxide diffusion volume (DLCO) was 30% - 79% of the predicted value (corrected by HB value), or FVC was 50% - 80% of the predicted value;
• (5) Blood biochemical examination should meet the following standards: alanine aminotransferase (ALT) ≤ 1.5uln, aspartate aminotransferase (AST) ≤ 1.5uln, total bilirubin (TBIL) ≤ 1.5uln, direct bilirubin (DBIL) ≤ 1.5uln, blood creatinine (CR) ≤ 1.5uln;
• (6) Expected survival ≥ 12 months;
• (7) Subjects who have good compliance, can understand and cooperate with the completion of pulmonary function examination, are willing to take drugs according to the requirements of the protocol and receive follow-up examination on time;
• (8) Subjects who voluntarily participated in the trial, understood and signed the informed consent form.