工研院與台大醫院合作開發「兩相材料軟硬骨關節修復技術」

具手術時間短、傷口小、復原快之特色

技術移轉美精技公司 進行全球臨床試驗

工研院與台大醫院歷經5年共同研發合作的「兩相材料軟硬骨關節修復技術」，於今（18）日與美精技台灣公司(Exactech Taiwan)進行技術移轉簽約。這項技術將於今年7月後在台大醫院進行人體臨床試驗。美精技公司也將同步展開全球性臨床試驗，以完成包括歐盟及美國等地區之產品上市作業。「兩相材料軟硬骨關節修復技術」具備可一次手術完成且手術時間短、傷口小、復原快的特點。  

工研院李鍾熙院長表示，「兩相材料軟硬骨關節修復技術」是由臺大醫師提出臨床需求與設計，結合工研院生醫材料技術共同研發，已申請7項專利，完成動物試驗，並技轉給骨科醫療器材領導廠商美精技公司。此技術完全由國人自行研發成功，除了具有技術領先的指標意義，亦將藉由美精技公司的產品開發經驗與國際行銷通路，進行臨床實驗及量產商業化，未來可望帶動國內骨科醫療器材產業。

 該研究計劃是由台大骨科部主 任江清泉 醫師及工研院 廖俊仁 博士共同主持。台大醫院林芳郁院長表示， 江清泉 醫師領導的團隊利用幹細胞和組織工程學的研究，將其應用於軟骨再生的創新技術，五年內於國際著名的醫學期刊發表六篇醫學論文，代表該團隊在軟骨再生的研究領域已達世界頂尖水準。  

江清泉 醫師說明，在手術過程，醫師僅需截取患部少量不受力處之健康軟骨切碎，浸泡於特殊酵素溶液中讓軟骨細胞游離出來，載入兩相多孔載體中，並植入患部，軟硬骨短期內便可自行增生修復。此技術的特點是，不需要體外培養軟骨細胞，病人僅需進行一次手術，而且手術時間短，傷口小，復原快。目前全球的軟骨修復技術僅能修補軟骨缺損，此創新技術則可同時修復軟骨及其下方骨頭之缺損，除了適用於年輕人因為運動傷害或外傷引起之關節軟骨缺損外，更適用於中老年人小範圍之關節炎和關節骨頭缺血性壞死，澤惠更多的關節病變病人。  

工研院生醫所留忠正所長表示，為推動此產品技術進入臨床應用，工研院團隊特別開發 方便 醫師於手術台上，短時間即可處理完成的自體組織之可拋棄式裝置、生物可吸收性骨材與微創手術器械，並於工研院設立生醫材料產品製造GMP工廠，進行相關植入物與套件之試量產。工研院生醫所 廖俊仁 博士進一步指出，由於工研院在相關產品技術的長期投入，此產品技術已通過臨床前之大型成熟豬隻動物臨床測試實驗，結果證實可有效修復深層關節軟硬骨損傷。  

長期致力於骨科人工關節植入物的美精技台灣公司負責人Bruce Thompson表示，此項技轉讓美精技公司能提前發展先端的關節軟骨修復及整型技術。此外，由於此技術牽涉到金屬器械及高分子可吸收材料，該公司亦將整合台灣骨科醫療器材產品GMP工廠，以進行相關產品技術開發。  

美精技公司（Exactech）介紹  

美精技公司位於美國佛州根斯維（Gainesville, Florida, USA），主要研發和行銷關節等骨骼的整型設備，產品多數在根斯維生產製作，提供醫療院所外科儀器和生物材料等相關服務，並在台灣成立子公司。該公司的整型產品，主要在重建因關節炎等骨頭與關節等疾病所造成的傷害。除了美國、澳洲，全球產品行銷超過25國，橫跨歐、亞洲與拉丁美洲。相關資訊可於公司網站 http://www.exac.com中查詢。

ITRI and NTU Hospital Develop Biphasic Osteochondral Repair for

Articular Cartilage Regeneration Technology

Short Procedure, Small Wound, Quick Recovery

Exactech Taiwan Licensed to Utilize Technology

 Professor Jiang explained that during surgery, physicians only need to extract small amounts of healthy cartilage from the damaged area. This material is then soaked in a special enzyme solution to release the cartilage cells. A biphasic porous scaffold is then implanted into the damaged area, enabling the cartilage to regenerate on its own in a short period. What makes this technology special is that there is no need to cultivate cartilage cells outside the body and that the patient needs to undergo only one surgery. This short surgery only leaves a small wound, and it offers the advantage of quick recovery. Presently, the most advanced osteochondral procedures only address repairing damaged cartilage. This new technology will both repair cartilage and the bone below it. This technology will be particularly beneficial to young people who suffer cartilage damage from sports or other external injuries. Middle-aged and older people who suffer from arthritis or whose joints or bones have been damaged due to poor blood flow will also be candidates for this procedure. 

ITRI Biomedical Engineering Research Laboratories General Director Dr. Chung-cheng Liu said that the ITRI research team has paid special attention to various processes and instruments to aid surgeons and promote the use of this technology in clinical applications. For instance, ITRI developed disposable devices that will treat autologous tissue in minimal time. It has also developed bio-absorbent bone materials and instruments enabling minimally invasive surgery. In addition, ITRI’s GMP-certified biomedical products factory carries out production of implants and kits of pilot scale. Dr. Chun-Jen Liao Ph.D., the lead researcher of biomaterial applications of the Biomedical Engineering Research Laboratories at ITRI, furthermore stated that ITRI has long engaged in research in related product technology. This technology has already passed large-scale trials on adult pigs in preparation for human clinical trials. The results of the trials on the pigs has confirmed the effectiveness in repairing osteochondral defects to the full thickness.   

The chief of the Ecaxtech Taiwan, Bruce Thompson said that Exactech Taiwan will be the recipient of technology transfers associated with biphasic osteochondral repair for articular cartilage regeneration. This technology license agreement allows Exactech to enter a field of treatment that is on the frontier of orthopaedics. Since this technology also concerns metallic instruments and resorbable biopolymers, Exactech intends to coordinate the development of related product technology among Taiwan ’s GMP-certified orthopaedic medical products factories.

 About NTUH

      Founded in 1895, the National Taiwan University Hospital is the most historical and important medical institute in Taiwan . The majority of physicians in the country have been trained in this hospital. The present chairman of the Department of Orthopaedic Surgery, Dr. Ching-Chuan Jiang, M.D., Ph.D., has studied in the Hospital for Special Surgery in New York , and is now the Director of the Cartilage Research Group of the NTUH. Additional information can be found at http://ntuh.mc.ntu.edu.tw/english/html/about/index.htm.

 About ITRI

The Industrial Technology Research Institute is the largest non-profit R/D organization in Taiwan . ITRI was founded in 1973 by the Ministry of Economic Affairs, Taiwan , to develop globally competitive and forward-looking technologies to meet industrial needs, to strengthen industrial competitiveness, and to enhance the economic growth of Taiwan . Additional information can be found at http://www.itri.org.tw.

  About Exactech