3B's Research Group-Biomaterials, Biodegradables and Biomimetics, European Institute of Excellence on Tissue Engineering and Regenerative Medicine, University of Minho, Barco GMR, Portugal.
ICVS/3B's-PT Government Associate Laboratory, Braga/Guimarães, Portugal.
Adv Exp Med Biol. 2018;1058:415-428. doi: 10.1007/978-3-319-76711-6_19.
The osteochondral tissue represents a complex structure composed of four interconnected structures, namely hyaline cartilage, a thin layer of calcified cartilage, subchondral bone, and cancellous bone. Due to the several difficulties associated with its repair and regeneration, researchers have developed several studies aiming to restore the native tissue, some of which had led to tissue-engineered commercial products. In this sense, this chapter discusses the good manufacturing practices, regulatory medical conditions and challenges on clinical translations that should be fulfilled regarding the safety and efficacy of the new commercialized products. Furthermore, we review the current osteochondral products that are currently being marketed and applied in the clinical setting, emphasizing the advantages and difficulties of each one.
软骨-骨组织是一种复杂的结构,由四种相互连接的结构组成,即透明软骨、薄的钙化软骨层、软骨下骨和松质骨。由于其修复和再生存在若干困难,研究人员已经开展了多项研究,旨在恢复天然组织,其中一些研究已促成了组织工程商业产品的问世。在这方面,本章讨论了新商业化产品的安全性和有效性方面应满足的良好生产规范、监管医疗条件和临床转化方面的挑战。此外,我们还综述了目前在临床应用中销售和使用的软骨-骨产品,强调了每种产品的优势和难点。