Muhamed Jaseer, Revi Deepa, Rajan Akhila, Geetha Surendran, Anilkumar Thapasimuthu V
Division of Experimental Pathology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India.
Division of Experimental Pathology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India
Toxicol Pathol. 2015 Jun;43(4):536-45. doi: 10.1177/0192623314550722. Epub 2014 Oct 14.
Comparative histomorphological assessment of local response to implanted reference biomaterial, also called biocompatibility testing/evaluation, in an appropriate animal model is a widely practiced safety evaluation procedure performed on biomaterials before clinical use. Standardized protocols and procedures, originally designed for testing synthetic materials, available for the testing/evaluation do not account for the immunogenic potential of a candidate biomaterial. Therefore, it is appropriate to supplement the routine biocompatibility test reports with adjunct data that may provide insight into the immunogenic potential of candidate biomaterials, especially when testing biomaterials that are derived from mammalian sources. This article presents expanded safety evaluation data of a porcine cholecyst-derived scaffold (CDS) intended as a xenogeneic graft. The biocompatibility was tested in rat subcutaneous model in comparison with a reference material and the CDS was found biocompatible. However, when studied by immunohistochemistry and real-time reverse transcription polymerase chain reaction for the number and/or polarization of M1 macrophage, M2 macrophage, cytotoxic T-cell, helper T cell, TH1 cell, and TH2 cell, the CDS appeared to induce a differential local immunopathological tissue reaction despite the similarity in biocompatibility with the reference material. The adjunct data collected were useful for objectively assessing the safety of CDS as a xenograft.
在合适的动物模型中，对植入的参考生物材料的局部反应进行比较组织形态学评估，也称为生物相容性测试/评价，是在生物材料临床使用前广泛实施的安全评估程序。最初为测试合成材料而设计的标准化方案和程序，可用于该测试/评价，但并未考虑候选生物材料的免疫原性潜力。因此，用可能提供有关候选生物材料免疫原性潜力见解的辅助数据来补充常规生物相容性测试报告是合适的，特别是在测试源自哺乳动物来源的生物材料时。本文展示了一种用作异种移植物的猪胆囊来源支架（CDS）的扩展安全评估数据。与参考材料相比，在大鼠皮下模型中测试了其生物相容性，发现CDS具有生物相容性。然而，当通过免疫组织化学和实时逆转录聚合酶链反应研究M1巨噬细胞、M2巨噬细胞、细胞毒性T细胞、辅助性T细胞、TH1细胞和TH2细胞的数量和/或极化时，尽管CDS与参考材料在生物相容性方面相似，但它似乎会诱导不同的局部免疫病理组织反应。收集的辅助数据有助于客观评估CDS作为异种移植物的安全性。
