2010-10-132024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/680173摘要：神經導管(Nerve conduits or nerve guidance channels)之功能在接合受損或斷裂的周邊神經，使其於導管內再生；目前臨床上的瓶頸為中間隙(1 cm以上)神經缺損的再生。本研究計畫擬針對本團隊最近幾年來發展設計出的一系列可分解新穎神經導管，進行臨床前開發與轉譯研究，以使此創新醫療器材產品能在未來進行臨床驗證，並順利上市而實際應用於臨床神經的修復。本團隊之新穎神經導管依照不同的設計與加值而發展出第一代(中間隙神經缺損)、第二代(中間隙~大間隙神經缺損)與第三代(大間隙神經缺損)的神經導管。第一代神經導管具有特殊非對稱孔洞及微溝槽結構(擁有一個專利)，第二代神經導管為在第一代導管中含入銀耳多醣(一個專利申請中)，第三代神經導管為第一代導管表面改質並含入生長因子FGF1 (擁有一個專利與兩個專利申請中)。本團隊開發之神經導管製程簡單，且目前基礎專利佈局已接近完成，期望經由本計畫研究成果獲得應用專利佈局策略，為未來產品上市作更嚴謹保護。本計畫擬結合跨領域執行團隊，經由本計畫的推動，達到神經導管臨床前開發與轉譯的目標。計畫中依據大鼠、兔及豬之動物實驗模式依序進行轉譯工作，同時規劃以完整的動物實驗數據申請使用GMP製程製作之導管進行臨床試驗，最終使神經導管通過上市申請，並順利行銷，以達到醫療器材在地化、培育生技產業之關鍵技術人力、扶植本土生技產業進行高附加價值醫療器材生產以及臨床神經修復等目的。<br> Abstract: Nerve conduits (or nerve guidance channels) are used to bridge the injured or transected nerve fibers. The current challenge is to repair the wider gap defect (> 1 cm). This project is to fabricate novel biodegradable nerve conduits developed from our team and perform the preclinical translational research to facilitate the implementation to the future clinical trials. The novel nerve conduits include the product design of three generations. The first generation conduits are microporous/microgrooved poly(D,L-lactide) conduits for regeneration of medium nerve gap defects (granted one patent). The second generation conduits are those grafted with Tremella fuciformis for repairing medium to large nerve gap defects (one pending patent). The third generation conduits are those grafted with FGF1 for repairing large nerve gap defects (one patent granted and two patents pending). The developed conduits have the advantage of convenient manufacturing processes. The layout of basic patents is almost finished. We expect that this project can help the layout of more application-oriented patents that should provide full protection of intellectual rights to our products. This project integrates active researchers from different areas and is truly interdisciplinary. After translation from rats and rabbits to pigs, we plan to apply clinical trials based on GMP manufactured conduits. Eventually, these products can be accredited, approved by the regulating authorities and be successfully marketed. This project can provide an opportunity for commercialization of a new medical device from Taiwan, train the key technical manpower, and support the medical device industry to produce high value-added medical devices for clinical use.神經導管周邊神經醫療器材動物實驗臨床試驗Nerve conduitsperipheral nervemedical devicesanimal studyclinical trial