Bench-to-Bedside Lessons Learned: Commercialization of an Acellular Nerve Graft.,Advanced Healthcare Materials

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Bench-to-Bedside Lessons Learned: Commercialization of an Acellular Nerve Graft.
Advanced Healthcare Materials ( IF 10.0 ) Pub Date : 2020-06-25 , DOI: 10.1002/adhm.202000174
Mary Kasper ₁ , Curt Deister ₂ , Florence Beck ₂ , Christine E Schmidt ₁

Affiliation

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.

中文翻译：

从台到床的经验教训：无细胞神经移植物的商业化。

周围神经损伤可导致虚弱的后果，包括功能丧失和神经性疼痛。尽管神经修复研究和治疗开发得到了广泛的研究，但是将这些想法转化为临床干预措施的速度却不尽相同。在本世纪初，周围神经修复的方法包括显微外科技术，空心导管和自体神经移植物。这些方法提供了令人满意的结果。但是，它们具有许多局限性，无法有效地进行手术治疗。Avance的商业化，一种经过处理的神经同种异体移植，试图通过提供一种现成的中空导管替代品，同时保持许多自体移植物的再生特性，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，用于治疗成千上万的患者。尽管Avance已成为外科医生和患者临床选择的重要补充，但该产品从长凳到床边的旅程花费了20多年的时间，面临许多研究和商业化挑战。本文回顾了将处理后的神经同种异体移植物从实验台带到患者床边的事件。此外，本评论提供了可以帮助将来的医疗产品翻译的课程和注意事项的观点。从长凳到床头的旅程历经20多年，面临许多研究和商业化挑战。本文回顾了将处理后的神经同种异体移植物从实验台带到患者床边的事件。此外，该评论提供了可以帮助将来的医疗产品翻译的课程和注意事项的观点。从长凳到床头的旅程历经20多年，面临许多研究和商业化挑战。本文回顾了将处理后的神经同种异体移植物从实验台带到患者床边的事件。此外，本评论提供了可以帮助将来的医疗产品翻译的课程和注意事项的观点。

更新日期：2020-08-19

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