Liu Chundi, Sun Mouyuan, Lin Lining, Luo Yaxian, Peng Lianjie, Zhang Jingyu, Qiu Tao, Liu Zhichao, Yin Jun, Yu Mengfei
Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, 310000, China.
The State Key Laboratory of Fluid Power and Mechatronic Systems, Key Laboratory of 3D Printing Process and Equipment of Zhejiang Province, School of Mechanical Engineering, Zhejiang University, Hangzhou, 310027, China.
Mater Today Bio. 2025 Feb 5;31:101503. doi: 10.1016/j.mtbio.2025.101503. eCollection 2025 Apr.
Peripheral nerve injuries are a prevalent global issue that has garnered great concern. Although autografts remain the preferred clinical approach to repair, their efficacy is hampered by factors like donor scarcity. The emergence of nerve guidance conduits as novel tissue engineering tools offers a promising alternative strategy. This review aims to interpret nerve guidance conduits and their commercialization from both clinical and laboratory perspectives. To enhance comprehension of clinical situations, this article provides a comprehensive analysis of the clinical efficacy of nerve conduits approved by the United States Food and Drug Administration. It proposes that the initial six months post-transplantation is a critical window period for evaluating their efficacy. Additionally, this study conducts a systematic discussion on the research progress of laboratory conduits, focusing on biomaterials and add-on strategies as pivotal factors for nerve regeneration, as supported by the literature analysis. The clinical conduit materials and prospective optimal materials are thoroughly discussed. The add-on strategies, together with their distinct obstacles and potentials are deeply analyzed. Based on the above evaluations, the development path and manufacturing strategy for the commercialization of nerve guidance conduits are envisioned. The critical conclusion promoting commercialization is summarized as follows: 1) The optimization of biomaterials is the fundamental means; 2) The phased application of additional strategies is the emphasized direction; 3) The additive manufacturing techniques are the necessary tools. As a result, the findings of this research provide academic and clinical practitioners with valuable insights that may facilitate future commercialization endeavors of nerve guidance conduits.
周围神经损伤是一个普遍存在的全球性问题,已引起广泛关注。尽管自体移植仍然是修复的首选临床方法,但其疗效受到供体稀缺等因素的阻碍。神经引导导管作为新型组织工程工具的出现提供了一种有前景的替代策略。本综述旨在从临床和实验室角度解读神经引导导管及其商业化。为了增强对临床情况的理解,本文对美国食品药品监督管理局批准的神经导管的临床疗效进行了全面分析。提出移植后的最初六个月是评估其疗效的关键窗口期。此外,本研究对实验室导管的研究进展进行了系统讨论,重点关注生物材料和附加策略作为神经再生的关键因素,文献分析提供了支持。对临床导管材料和潜在的最佳材料进行了深入讨论。对附加策略及其独特的障碍和潜力进行了深入分析。基于上述评估,设想了神经引导导管商业化的发展路径和制造策略。促进商业化的关键结论总结如下:1)生物材料的优化是根本手段;2)附加策略的分阶段应用是重点方向;3)增材制造技术是必要工具。因此,本研究结果为学术和临床从业者提供了有价值的见解,可能有助于神经引导导管未来的商业化努力。
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