Owen G Rh, Meredith D O, ap Gwynn I, Richards R G
New York Structural Biology Centre, New York 10027, USA.
Eur Cell Mater. 2005 Jun 23;9:85-96; discussion 85-96. doi: 10.22203/ecm.v009a10.
The development of novel synthetic biomaterials is necessitated by the increasing demand for accelerated healing of tissues following surgical intervention. Strict testing of such materials is necessary before application. Currently, before any material can be marketed, approval by regulatory organisations such as the FDA is required. Presently, in vitro testing is performed as a prerequisite to in vivo evaluation. The in vitro techniques currently employed do not reflect the progress in our understanding of extra and intra-cellular processes, with far more sensitive in vitro evaluations now available. Obtaining quantifiable data is increasingly relevant to evaluating events occurring in vivo. Quantifying cell adhesion to surfaces provides some of this data as an initial assessment method. Major developments in this field are occurring but many investigators still use less than optimal methods for assessing biomaterials. The relevance of using cell adhesion assays to help determine biomaterial biocompatibility is reviewed. Additionally, current in vitro methods of evaluating biomaterials are discussed in the context of novel testing concepts developed by the authors.
手术干预后对组织加速愈合的需求不断增加,这使得新型合成生物材料的研发成为必要。在应用此类材料之前,必须进行严格测试。目前,任何材料在上市之前,都需要获得美国食品药品监督管理局等监管机构的批准。目前,体外测试是体内评估的先决条件。当前采用的体外技术并未反映出我们在细胞外和细胞内过程理解方面的进展,现在已有更为灵敏的体外评估方法。获取可量化数据对于评估体内发生的事件越来越重要。量化细胞与表面的粘附提供了一些此类数据,作为一种初步评估方法。该领域正在取得重大进展,但许多研究人员仍使用不太理想的方法来评估生物材料。本文综述了使用细胞粘附试验来帮助确定生物材料生物相容性的相关性。此外,还结合作者提出的新型测试概念,讨论了当前评估生物材料的体外方法。