Mansour Joseph M, Welter Jean F
Skeletal Research Center, Department of Biology Case Western Reserve University Cleveland, OH, 44106.
J Med Biol Eng. 2013 Feb 1;33(1):1-16. doi: 10.5405/jmbe.1254.
Tissue engineering (TE) has promise as a biological solution and a disease modifying treatment for arthritis. Although cartilage can be generated by TE, substantial inter- and intra-donor variability makes it impossible to guarantee optimal, reproducible results. TE cartilage must be able to perform the functions of native tissue, thus mechanical and biological properties approaching those of native cartilage are likely a pre-requisite for successful implantation. A quality-control assessment of these properties should be part of the implantation release criteria for TE cartilage. Release criteria should certify that selected tissue properties have reached certain target ranges, and should be predictive of the likelihood of success of an implant . Unfortunately, it is not currently known which properties are needed to establish release criteria, nor how close one has to be to the properties of native cartilage to achieve success. Achieving properties approaching those of native cartilage requires a clear understanding of the target properties and reproducible assessment methodology. Here, we review several main aspects of quality control as it applies to TE cartilage. This includes a look at known mechanical and biological properties of native cartilage, which should be the target in engineered tissues. We also present an overview of the state of the art of tissue assessment, focusing on native articular and TE cartilage. Finally, we review the arguments for developing and validating non-destructive testing methods for assessing TE products.
组织工程(TE)有望成为治疗关节炎的一种生物学解决方案和疾病改善疗法。尽管通过组织工程可以生成软骨,但供体间和供体内的显著差异使得无法保证获得最佳的、可重复的结果。组织工程软骨必须能够履行天然组织的功能,因此,其力学和生物学特性接近天然软骨很可能是成功植入的一个先决条件。对这些特性进行质量控制评估应成为组织工程软骨植入放行标准的一部分。放行标准应证明所选组织特性已达到特定目标范围,并应能预测植入成功的可能性。不幸的是,目前尚不清楚确立放行标准需要哪些特性,也不清楚与天然软骨的特性接近到何种程度才能取得成功。要获得接近天然软骨的特性,需要清楚了解目标特性和可重复的评估方法。在此,我们综述了适用于组织工程软骨的质量控制的几个主要方面。这包括审视天然软骨已知的力学和生物学特性,而这应该是工程组织的目标。我们还概述了组织评估的技术现状,重点是天然关节软骨和组织工程软骨。最后,我们综述了开发和验证用于评估组织工程产品的无损检测方法的理由。