Kasper Mary, Deister Curt, Beck Florence, Schmidt Christine E
J. Crayton Pruitt Family Department of Biomedical Engineering, University of Florida, Gainesville, FL, 32611, USA.
Axogen Corporation, Alachua, FL, 32615, USA.
Adv Healthc Mater. 2020 Aug;9(16):e2000174. doi: 10.1002/adhm.202000174. Epub 2020 Jun 25.
Peripheral nerve injury can result in debilitating outcomes including loss of function and neuropathic pain. Although nerve repair research and therapeutic development are widely studied, translation of these ideas into clinical interventions has not occurred at the same rate. At the turn of this century, approaches to peripheral nerve repair have included microsurgical techniques, hollow conduits, and autologous nerve grafts. These methods provide satisfactory results; however, they possess numerous limitations that can prevent effective surgical treatment. Commercialization of Avance, a processed nerve allograft, sought to address limitations of earlier approaches by providing an off-the-shelf alternative to hollow conduits while maintaining many proregenerative properties of autologous grafts. Since its launch in 2007, Avance has changed the landscape of the nerve repair market and is used to treat tens of thousands of patients. Although Avance has become an important addition to surgeon and patient clinical options, the product's journey from bench to bedside took over 20 years with many research and commercialization challenges. This article reviews the events that have brought a processed nerve allograft from the laboratory bench to the patient bedside. Additionally, this review provides a perspective on lessons and considerations that can assist in translation of future medical products.
周围神经损伤可导致包括功能丧失和神经性疼痛在内的使人衰弱的后果。尽管神经修复研究和治疗开发得到了广泛研究，但这些理念转化为临床干预措施的速度却不尽相同。在本世纪之交，周围神经修复方法包括显微外科技术、中空导管和自体神经移植。这些方法取得了令人满意的结果；然而，它们存在许多局限性，可能会妨碍有效的手术治疗。一种经过处理的同种异体神经移植产品Avance的商业化，旨在通过提供一种现成的中空导管替代品，同时保持自体移植物的许多促再生特性，来解决早期方法的局限性。自2007年推出以来，Avance改变了神经修复市场的格局，已用于治疗数万名患者。尽管Avance已成为外科医生和患者临床选择中的重要补充，但该产品从实验室到临床的历程耗时20多年，面临诸多研究和商业化挑战。本文回顾了将一种经过处理的同种异体神经移植产品从实验室带到患者床边的一系列事件。此外，本综述还提供了一些经验教训和思考，有助于未来医疗产品的转化。
