A novel method for evaluating the dynamic biocompatibility of degradable biomaterials based on real-time cell analysis

Author:

Gai Xiaoxiao123,Liu Chenghu123,Wang Guowei123,Qin Yang123,Fan Chunguang123,Liu Jia123,Shi Yanping123

Affiliation:

1. Department of Biological Evaluation, Shandong Quality Inspection Center for Medical Devices, NO.15166 Century Avenue, H-T Industrial Development Zone, Jinan 250101, China

2. Shandong Key Laboratory of Biological Evaluation for Medical Devices, NO.15166 Century Avenue, H-T Industrial Development Zone, Jinan 250101, China

3. Department of Biological Evaluation, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, NO.15166 Century Avenue, H-T Industrial Development Zone, Jinan 250101, China

Abstract

Abstract Degradable biomaterials have emerged as a promising type of medical materials because of their unique advantages of biocompatibility, biodegradability and biosafety. Owing to their bioabsorbable and biocompatible properties, magnesium-based biomaterials are considered as ideal degradable medical implants. However, the rapid corrosion of magnesium-based materials not only limits their clinical application but also necessitates a more specific biological evaluation system and biosafety standard. In this study, extracts of pure Mg and its calcium alloy were prepared using different media based on ISO 10993:12; the Mg2+ concentration and osmolality of each extract were measured. The biocompatibility was investigated using the MTT assay and xCELLigence real-time cell analysis (RTCA). Cytotoxicity tests were conducted with L929, MG-63 and human umbilical vein endothelial cell lines. The results of the RTCA highly matched with those of the MTT assay and revealed the different dynamic modes of the cytotoxic process, which are related to the differences in the tested cell lines, Mg-based materials and dilution rates of extracts. This study provides an insight on the biocompatibility of biodegradable materials from the perspective of cytotoxic dynamics and suggests the applicability of RTCA for the cytotoxic evaluation of degradable biomaterials.

Funder

National Key Research and Development Project of China

Publisher

Oxford University Press (OUP)

Subject

Biomaterials

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