Clinic and Policlinic for Dermatology and Venereology, University Medical Center Rostock, 18057 Rostock, Germany.
Beijing Advanced Innovation Center for Soft Matter Science and Engineering, College of Life Science and Technology, Beijing University of Chemical Technology, Beijing 100013, China.
Int J Mol Sci. 2023 Feb 3;24(3):3007. doi: 10.3390/ijms24033007.
Cytocompatibility analyses of new implant materials or biomaterials are not only prescribed by the Medical Device Regulation (MDR), as defined in the DIN ISO Norm 10993-5 and -12, but are also increasingly replacing animal testing. In this context, jellyfish collagen has already been established as an alternative to mammalian collagen in different cell culture conditions, but a lack of knowledge exists about its applicability for cytocompatibility analyses of biomaterials. Thus, the present study was conducted to compare well plates coated with collagen type 0 derived from with plates coated with bovine and porcine collagen. The coated well plates were analysed in vitro for their cytocompatibility, according to EN ISO 10993-5/-12, using both L929 fibroblasts and MC3T3 pre-osteoblasts. Thereby, the coated well plates were compared, using established materials as positive controls and a cytotoxic material, RM-A, as a negative control. L929 cells exhibited a significantly higher viability (#### < 0.0001), proliferation (## < 0.01), and a lower cytotoxicity (## < 0.01 and # < 0.05)) in the Jellagen® group compared to the bovine and porcine collagen groups. MC3T3 cells showed similar viability and acceptable proliferation and cytotoxicity in all collagen groups. The results of the present study revealed that the coating of well plates with collagen Type 0 derived from leads to comparable results to the case of well plates coated with mammalian collagens. Therefore, it is fully suitable for the in vitro analyses of the cytocompatibility of biomaterials or medical devices.
新植入材料或生物材料的细胞相容性分析不仅按照医疗器械法规(MDR)的要求(DIN ISO 标准 10993-5 和 -12 中定义),而且也越来越多地取代动物试验。在这方面,水母胶原蛋白已在不同的细胞培养条件下被证明是哺乳动物胶原蛋白的替代品,但对于生物材料的细胞相容性分析的适用性,仍缺乏相关知识。因此,本研究旨在比较用源自 的胶原蛋白 0 型包被的培养板与用牛和猪胶原蛋白包被的培养板。根据 EN ISO 10993-5/-12,使用 L929 成纤维细胞和 MC3T3 前成骨细胞,对包被的培养板进行体外细胞相容性分析。在此过程中,使用已建立的材料作为阳性对照和细胞毒性材料 RM-A 作为阴性对照,对包被的培养板进行比较。与牛和猪胶原蛋白组相比,L929 细胞在 Jellagen®组中表现出更高的活力(#### < 0.0001)、增殖(## < 0.01)和更低的细胞毒性(## < 0.01 和 # < 0.05)。MC3T3 细胞在所有胶原蛋白组中表现出相似的活力和可接受的增殖和细胞毒性。本研究的结果表明,用源自 的胶原蛋白 0 型包被培养板可获得与用哺乳动物胶原蛋白包被培养板相似的结果。因此,它完全适用于生物材料或医疗器械的体外细胞相容性分析。