Silk fibroin (Bombyx mori) was used to manufacture a nerve conduit (SilkBridgeTM) characterized by a novel 3D architecture. The wall of the conduit consists of two electrospun layers (inner and outer) and one textile layer (middle), perfectly integrated at the structural and functional level. The manufacturing technology conferred high compression strength on the device, thus meeting clinical requirements for physiological and pathological compressive stresses. As demonstrated in a previous work, the silk material has proven to be able to provide a valid substrate for cells to grow on, differentiate and start the fundamental cellular regenerative activities in vitro and, in vivo, at the short time point of 2 weeks, to allow the starting of regenerative processes in terms of good integration with the surrounding tissues and colonization of the wall layers and of the lumen with several cell types. In the present study, a 10 mm long gap in the median nerve was repaired with 12 mm SilkBridgeTM conduit and evaluated at middle (4 weeks) and at longer time points (12 and 24 weeks). The SilkBridgeTM conduit led to a very good functional and morphological recovery of the median nerve, similar to that observed with the reference autograft nerve reconstruction procedure. Taken together, all these results demonstrated that SilkBridgeTM has an optimized balance of biomechanical and biological properties, which allowed proceeding with a first-in-human clinical study aimed at evaluating safety and effectiveness of using the device for the reconstruction of digital nerve defects in humans.

中文翻译：

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SilkBridgeTM 用于外周神经再生的临床前验证

丝素蛋白 (Bombyx mori) 用于制造以新型 3D 结构为特征的神经导管 (SilkBridgeTM)。导管壁由两层电纺层（内层和外层）和一层纺织层（中间）组成，在结构和功能层面完美结合。该制造技术赋予设备高抗压强度，从而满足生理和病理压缩应力的临床要求。正如之前的工作所证明的那样，丝材料已被证明能够为细胞在体外和体内的 2 周短时间点上生长、分化和启动基本的细胞再生活动提供有效的基质，允许在与周围组织的良好整合以及壁层和管腔与多种细胞类型的定居方面开始再生过程。在本研究中，正中神经中 10 毫米长的间隙用 12 毫米 SilkBridgeTM 导管修复，并在中期（4 周）和更长的时间点（12 周和 24 周）进行评估。SilkBridgeTM 导管使正中神经获得了非常好的功能和形态恢复，类似于参考自体移植神经重建程序所观察到的恢复。综上所述，所有这些结果表明 SilkBridgeTM 具有生物力学和生物学特性的优化平衡，