动物源性脱细胞基质类材料的免疫原性:风险分析与评价

Immunogenicity of animal-tissue derived decellularized ECM:risk analysis and evaluation

动物源性脱细胞基质类材料具有与人体组织类似的基质结构,因良好的生物相容性和组织诱导性,被广泛应用于临床患者的组织修复和重建等再生医疗领域。但由于这类材料的特殊来源,需要关注的特殊风险包括潜在外源因子污染、异种细胞及其免疫原残留和脱细胞工艺试剂残留等导致的一系列不期望的热原、免疫原及炎症等材料反应。本文针对动物源性脱细胞基质类材料的风险分析、控制与评价进行综述。重点分析论述目前已初步建立的一些相关风险评价技术、方法和标准,最后展望了亟待完善的系统化质量评价体系。

Animal tissue-derived decellularized extrocellular matrix(dECM)materials have similar matrix structure to human tissue.Due to their good biocompatibility and tissue inducing potential,they are widely used in the field of tissue repair and reconstruction clinically.The special risks caused by such materials are a series of unexpected material-mediated reactions,such as pyrogen,immunogen and inflammation caused by potential adventitious agents,xenogeneic cells and their immunogen residues and reagent residues in decellularization processes,and are needed to be paid attention to.Here,the risk analysis,risk control and risk evaluation of animal tissue-derived dECM materials were reviewed.Some relevant assessment technologies,methods and standards that have been preliminarily established at present were mainly reviewed and discussed.Finally,this paper looks forward to a more systematic quality evaluation system that needs to be improved.