Department of Medical Devices, National Institutes for Food and Drug Control, Beijing 102629, China.
Int J Mol Sci. 2024 Oct 11;25(20):10963. doi: 10.3390/ijms252010963.
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.
免疫毒性评估在可植入动物源性生物材料的临床前测试中至关重要,因为这些材料与人体长时间接触,需要进行严格的安全性评估。本研究通过建立具有不同免疫毒性水平的实验模型,揭示了脱细胞处理在降低材料免疫原性方面的决定性作用,从而确保了临床安全性。研究采用先进的差异基因表达分析方法,不仅准确地量化了免疫反应中基因表达的变化,还通过通路富集分析,确定了与癌变相关的基因网络。这为生物材料植入后免疫反应的机制提供了新的见解。此外,该研究还强调了开发高灵敏度免疫毒性测试方法的重要性,并验证了高通量测序和生物信息学工具在评估生物材料安全性方面的有效性,为未来的临床前评估提供了强有力的科学支持。