Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials

IMR OpenIR

	Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials
	Wang, Jiali; Witte, Frank; Xi, Tingfei; Zheng, Yufeng; Yang, Ke; Yang, Yuansheng; Zhao, Dewei; Meng, Jian; Li, Yangde; Li, Weirong; Chan, Kaiming; Qin, Ling; qin@ort.cuhk.edu.hk
	2015
发表期刊	ACTA BIOMATERIALIA
ISSN	1742-7061
卷号	21 页码:237-249
摘要	As one of the most promising medical metal implants, magnesium (Mg) or its alloys have shown significant advantages over other candidates attributed to not only their excellent biodegradability and suitable mechanical properties but also their osteopromotive effects for bone applications. Prior to approval mandated by the governmental regulatory body, the access to the medical market for Mg-based implants requires a series of testing for assurance of their safety and efficacy via preclinical evaluations and clinical tests including phase 1 and 2 evaluations, and phase 3 of multi-center randomized double blind and placebo-controlled clinical trials. However, as the most widely used protocols for biosafety evaluation of medical devices, current ISO 10993 standards should be carefully reevaluated when directly applying them to predict potential health risks of degradable Mg based biomaterials via cytotoxicity tests due to the huge gap between in vitro and in vivo conditions. Therefore, instead of a direct adoption, modification of current ISO standards for in vitro cytotoxicity test is desirable and justified. The differences in sensitivities of cells to in vitro and in vivo Mg ions and the capability of in vivo circulation system to dilute local degradation products were fully considered to propose modification of current ISO standards. This paper recommended a minimal 6 times to a maximal 10 times dilution of extracts for in vitro cytotoxicity test specified in ISO 10993 part 5 for pure Mg developed as potential orthopedic implants based on literature review and our specifically designed in vitro and in vivo tests presented in the study. Our work may contribute to the progress of biodegradable metals involved translational work. (C) 2015 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.
部门归属	[wang, jiali ; chan, kaiming ; qin, ling] chinese univ hong kong, dept orthopaed & traumatol, musculoskeletal res lab, hong kong, hong kong, peoples r china ; [wang, jiali ; qin, ling] chinese acad sci, inst biomed & hlth engn, ctr translat med res & dev, shenzhen 518055, peoples r china ; [witte, frank] charite, julius wolff inst, d-13353 berlin, germany ; [witte, frank] charite, berlin brandenburg ctr regenerat therapies, ctr musculoskeletal surg, d-13353 berlin, germany ; [xi, tingfei] peking univ, acad adv interdisciplinary studies, ctr biomed mat & tissue engn, beijing 100871, peoples r china ; [zheng, yufeng] peking univ, state key lab turbulence & complex syst, beijing 100871, peoples r china ; [zheng, yufeng] peking univ, dept mat sci & engn, coll engn, beijing 100871, peoples r china ; [yang, ke ; yang, yuansheng] chinese acad sci, inst met res, shenyang 110016, peoples r china ; [zhao, dewei] dalian univ, affiliated zhongshan hosp, dept orthoped, dalian 116622, peoples r china ; [meng, jian] chinese acad sci, china changchun inst appl chem, changchun 130022, peoples r china ; [wang, jiali ; xi, tingfei ; zheng, yufeng ; yang, ke ; yang, yuansheng ; meng, jian ; li, yangde ; li, weirong ; qin, ling] dongguan e ande co ltd, guangdong innovat team biodegradable magnesium &, dongguan, peoples r china ; [wang, jiali] shenzhen bioact mat engn lab med, shenzhen 518055, peoples r china
关键词	Biometal Magnesium Biodegradability Cytotoxicity Iso Standards
资助者	Hong Kong Collaborative Research Fund [CRF 2014/15-C4028-14GF]; Guangdong Innovation Team Grant on Biodegradable Magnesium and Medical Implants [201001C0104669453]; National Natural Science Foundation of China (NSFC)/Research Grants Council (RGC) Joint Research Scheme [N_CUHK449/13]; Chinese Academy of Sciences-Croucher Founding Scheme for Joint Laboratories [CAS 14303]; SMART Program, Lui Che Woo Institute of Innovative Medicine, Faculty of Medicine, the Chinese University of Hong Kong - Lui Che Woo Foundation Limited
收录类别	sci
语种	英语
WOS记录号	WOS:000356546500021
引用统计	被引频次：499[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	http://ir.imr.ac.cn/handle/321006/75090
专题	中国科学院金属研究所
通讯作者	qin@ort.cuhk.edu.hk
推荐引用方式 GB/T 7714	Wang, Jiali,Witte, Frank,Xi, Tingfei,et al. Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials[J]. ACTA BIOMATERIALIA,2015,21:237-249.
APA	Wang, Jiali.,Witte, Frank.,Xi, Tingfei.,Zheng, Yufeng.,Yang, Ke.,...&qin@ort.cuhk.edu.hk.(2015).Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials.ACTA BIOMATERIALIA,21,237-249.
MLA	Wang, Jiali,et al."Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials".ACTA BIOMATERIALIA 21(2015):237-249.