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首页> 外文期刊>Tissue engineering, Part B. Reviews >Establishment of a preclinical ovine model for tibial segmental bone defect repair by applying bone tissue engineering strategies.
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Establishment of a preclinical ovine model for tibial segmental bone defect repair by applying bone tissue engineering strategies.

机译：通过应用骨组织工程策略建立胫骨节段性骨缺损修复的临床前绵羊模型。

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Currently, well-established clinical therapeutic approaches for bone reconstruction are restricted to the transplantation of autografts and allografts, and the implantation of metal devices or ceramic-based implants to assist bone regeneration. Bone grafts possess osteoconductive and osteoinductive properties; however, they are limited in access and availability and associated with donor-site morbidity, hemorrhage, risk of infection, insufficient transplant integration, graft devitalization, and subsequent resorption resulting in decreased mechanical stability. As a result, recent research focuses on the development of alternative therapeutic concepts. The field of tissue engineering has emerged as an important approach to bone regeneration. However, bench-to-bedside translations are still infrequent as the process toward approval by regulatory bodies is protracted and costly, requiring both comprehensive in vitro and in vivo studies. The subsequent gap between research and clinical translation, hence, commercialization, is referred to as the "Valley of Death" and describes a large number of projects and/or ventures that are ceased due to a lack of funding during the transition from product/technology development to regulatory approval and subsequently commercialization. One of the greatest difficulties in bridging the Valley of Death is to develop good manufacturing processes and scalable designs and to apply these in preclinical studies. In this article, we describe part of the rationale and road map of how our multidisciplinary research team has approached the first steps to translate orthopedic bone engineering from bench to bedside by establishing a preclinical ovine critical-sized tibial segmental bone defect model, and we discuss our preliminary data relating to this decisive step.
机译：当前，用于骨重建的公认的临床治疗方法限于自体移植物和同种异体移植物的移植，以及金属装置或基于陶瓷的植入物的移植以辅助骨再生。骨移植物具有骨传导和骨诱导特性;但是，它们的获取和可用性受到限制，并且与供体部位的发病率，出血，感染的风险，移植物整合不足，移植物失活以及随后的吸收相关，从而导致机械稳定性下降。结果，最近的研究集中在替代治疗概念的发展上。组织工程领域已经成为骨再生的重要方法。但是，由于需要获得监管机构批准的过程既漫长又昂贵，因此从台式到台式的翻译仍然很少见，需要进行全面的体外和体内研究。随后的研究与临床翻译之间的差距，即商业化，被称为“死亡谷”，描述了由于从产品/技术过渡期间缺乏资金而停止的大量项目和/或企业发展到监管部门批准，然后商业化。弥合死亡之谷的最大困难之一是开发良好的制造工艺和可扩展的设计，并将其应用于临床前研究中。在本文中，我们描述了我们的多学科研究团队如何通过建立临床前绵羊临界尺寸的胫骨节段性骨缺损模型，迈出了第一步，将整形外科的骨工程学从长凳转化为床旁的基本原理和路线图，并讨论了我们有关此决定性步骤的初步数据。

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