Abstract
Immunotoxicity evaluation has been crucial in preclinical testing for implantable animal-derived biomaterials due to their prolonged contact with the human body, which requires stringent safety assessments. By creating experimental models with varying levels of immunotoxicity, this study reveals the decisive role of decellularization treatment in diminishing the immunogenicity of materials, thus ensuring clinical safety. Employing cutting-edge differential gene expression analysis, the research not only accurately quantifies gene expression alterations in immune responses but also, through pathway enrichment analysis, identifies gene networks associated with oncogenesis. This offers novel insights into the mechanisms of immune responses following biomaterial implantation. Additionally, the study highlights the importance of developing highly sensitive immunotoxicity testing methods and validates the efficacy of high-throughput sequencing and bioinformatics tools in assessing biomaterial safety, providing robust scientific support for future preclinical evaluations.