Bassani Giulia Alessandra, Vincoli Valentina, Biagiotti Marco, Valsecchi Elisa, Zucca Marta Virginia, Clavelli Claudia, Alessandrino Antonio, Freddi Giuliano
Silk Biomaterials Srl, 22074 Lomazzo, Como, Italy.
Insects. 2022 Feb 21;13(2):212. doi: 10.3390/insects13020212.
The medical device is a nerve conduit entirely made of silk fibroin. It is a tubular scaffold used for repairing peripheral nerve gaps, whose function is to protect the severed nerves and to favor their natural healing process. As any implantable medical device, the conduit must perform its function without causing adverse effects to the patient, meaning that it must be compliant with a range of regulations aimed at evaluating the risks related to the constituent materials and the manufacturing process, the toxicological impact of the processing aids, the biological safety, the functional performance, and the ability to sustain tissue regeneration processes. An exhaustive on-bench testing plan has been performed for the determination of the morphological, geometrical, physical, structural, and mechanical properties. For the toxicological analysis, the device was extracted with solvent and the number of leachable substances was determined by suitable chromatographic techniques. The biological safety was assessed by means of a set of tests, including cytotoxicity, delayed hypersensitivity, intracutaneous reactivity, pyrogen test, LAL (Limulus Amebocyte Lysate) test, acute systemic toxicity, and genotoxicity. Overall, the accumulated results demonstrated the suitability of the device for the intended use and supported the starting of a first-in-human clinical trial.
该医疗器械是一种完全由丝素蛋白制成的神经导管。它是一种用于修复周围神经间隙的管状支架，其功能是保护切断的神经并促进其自然愈合过程。作为任何可植入医疗器械，该导管必须在不对患者造成不利影响的情况下发挥其功能，这意味着它必须符合一系列法规，这些法规旨在评估与组成材料和制造过程相关的风险、加工助剂的毒理学影响、生物安全性、功能性能以及维持组织再生过程的能力。为了确定其形态、几何、物理、结构和机械性能，已经执行了详尽的台架测试计划。对于毒理学分析，用溶剂提取该装置，并通过合适的色谱技术确定可浸出物质的数量。通过一系列测试评估生物安全性，包括细胞毒性、迟发型超敏反应、皮内反应性、热原试验、LAL（鲎试剂）试验、急性全身毒性和遗传毒性。总体而言，累积结果证明了该装置适用于预期用途，并支持启动首次人体临床试验。
