Günther K, Scharf H P, Puhl W
Orthopädische Klinik, Universität Ulm.
Biomed Tech (Berl). 1993 Oct;38(10):249-54. doi: 10.1515/bmte.1993.38.10.249.
Prior to the clinical use of synthetic bone substitutes and allogenic bone transplants, potential toxicity resulting from various different manufacturing, storage, and sterilisation techniques should be excluded. In order to develop a reliable and reproducible in vitro model for the investigation of possible tissue reactions after implantation of biomaterials, we modified an established animal fibroblast culture technique used to test chemical agents for acute unspecific cytotoxicity. Subcultivation of human fibroblasts produces stable monolayer cultures with the aid of which, standardised, accurate and reproducible evaluation of toxic effects, as well as the direct visualisation of fibroblast ingrowth into porous implant material, is possible. Gamma-irradiated synthetic implants and bovine hydroxyapatite failed to show any substantial cytotoxicity. In contrast, ethylene oxide sterilised implant material, as well as fresh untreated trabecular bone showed a significant toxic effect in comparison with cryopreserved and autoclaved trabecular bone.
在合成骨替代物和同种异体骨移植临床应用之前，应排除各种不同制造、储存和灭菌技术导致的潜在毒性。为了开发一种可靠且可重复的体外模型，用于研究生物材料植入后可能的组织反应，我们改进了一种既定的动物成纤维细胞培养技术，该技术用于测试化学试剂的急性非特异性细胞毒性。人成纤维细胞的传代培养可产生稳定的单层培养物，借助该培养物，可以对毒性作用进行标准化、准确且可重复的评估，以及直接观察成纤维细胞向多孔植入材料内生长的情况。γ射线辐照的合成植入物和牛羟基磷灰石未显示出任何实质性的细胞毒性。相比之下，与冷冻保存和高压灭菌的小梁骨相比，环氧乙烷灭菌的植入材料以及新鲜未处理的小梁骨显示出显著的毒性作用。
