日本頂尖幹細胞團隊來台 台日進行臨床實驗合作指日可待 信傳媒 鄭國強 2018年7月5日在全球萬能誘導幹細胞（iPSC）治療占有領先地位的日本京都大學、日本理化學研究所、東京女子醫科大學等團隊於6月30日來台參加由台北榮總主辦的「台日幹細胞治療與再生醫學會議」，並獲得日本臺灣交流協會、台日科交會、衛福部、科技部的支持，尤其在6月初衛服部公告將開放部分項自體細胞治療之際，這次交流顯得別具意義。這次來台日本學者幾乎涵蓋最先進自體幹細胞治療的精英，例如完成世界首例自體iPSC視網膜幹細胞移植的日本理化學研究所高橋政代（Masayo Takahashi）教授。以3D Cell Sheet立體細胞組織合成再生技術能夠形成七種器官的東京女子醫科大學所長清水達也（Tatsuya Shimizu）、京都大學iPS細胞研究中心副所長齊藤博英 （Hirohide Saito）、長船健二（Kenji Osafune）與金子新（Shin Kaneko）教授等，來台分享日本再生醫學的發展及最新幹細胞治療運用的趨勢。
日本政府投1千億，發展iPSC細胞研究 由於京都大學教授山中伸彌在2006年就成功研究出可以衍生成人類其他器官細胞的iPSC，竟然在2012年就獲得諾貝爾生理學與醫學獎，根據《日經中文網》的報導，日本政府便以此為契機，決定10年投入1100億日元支援以iPSC細胞為中心的再生醫療研究。日本政府期待，如果能夠成功將iPSC細胞推向實用化，將在全球再生醫療領域成為領頭羊，第一步從鬆綁法規開始。30日當天，談到日本在iPSC領先全球的地位，衛福部部長陳時中指出，2014年日本國會頒布了兩項新法規，一項是藥事法修訂版《藥品、醫療器材和其他治療產品法案》，另一項為《再生醫療安全管理法案》，並於誘導型多功能幹細胞研究領域投注大量資源，造就日本躍昇再生醫療領域為最具成長潛力的國家，促使相關再生醫療研發成果，居世界領先地位。由於法規鬆綁，在臨床運用治療上，日本於2014年開放iPSC進行眼睛臨床試驗，2017年則已核准利用iPSC來治療帕金森氏症的實驗，而在今年5月也核准了iPSC利用層狀培養的技術運用在心臟疾病的治療實驗，一般而言，需要2到3年才能有更進一步的結果。相較之下，陳時中指出，台灣為推動生技醫藥使之作為五大創新產業之一，行政院積極推動相關法規鬆綁，經濟部也提出攸關生技產業發展的《生技新藥條例》修正案，立法院院會並於2016年底三讀通過《生技新藥產業發展條例》修正案，以鼓勵產業投入細胞治療領域新技術、新產品的開發，他認為這次台日雙方交流與經驗分享，將可以加速台灣再生醫學的推動。
台日醫療交流，有機會合作臨床實驗 若從台日醫療交流的角度來看，日本臺灣交流協會臺北事務所首席副代表橫田光弘指出，近年日本政府大力推動再生醫療產業化，使得日本國內再生醫學研究與產業快速發展，這次台日交流，將會帶領雙方再生醫學發展向前邁進一大步，將更深化兩國關係並增加未來雙方合作之契機，他還說，日台係共同擁有自由、民主主義、基本人權、法律支配之基本價值的重要夥伴，日本台灣交流協會將繼續竭盡全力，使日台關係更上層樓。值得一提的是，為何日本相關頂尖幹細胞研究單位選擇與台北榮總合作？台北榮總院長張德明透露，原來去年3月份本院陳勢安副院長率隊參訪日本京都大學附設醫院，並於去年6月就與京都大學附設醫院簽署為合作醫院。而台北榮總醫學研究部教授邱士華更與視網膜研究領域首屈一指的單位「日本理化學研究所」高橋政代教授簽定MOU。由於台灣有良好的醫療體系與臨床經驗，因此日本研究單位對於台日合作於更多項目的幹細胞臨床實驗議題非常感到興趣，台灣在細胞治療領域也有機會能站在世界的前端，並在與韓國、中國的競爭中取得優勢。
365 days: Nature's 10/ Ten people who mattered this year.
17 December 2014 MASAYO TAKAHASHI: Stem-cell tester An ophthalmologist injected hope into the stem-cell field during a troubled year. By David Cyranoski. For an hour on Friday 12 September, Masayo Takahashi sat alone, calmly reflecting on the decade of research that had led up to this moment.An ophthalmologist at the RIKEN Center for Developmental Biology (CDB) in Kobe, Japan, Takahashi was about to watch a sheet of epithelial cells that she had grown be transplanted into the back of a woman's damaged retina. She had made the cells from induced pluripotent stem (iPS) cells, which have been widely touted for their potential to generate genetically-matched tissue for treating a range of diseases. The transplant would be the first test of that promise in people, and therefore a major milestone for the stem-cell field. As she sat, Takahashi quietly considered all those who had helped her get to that point (“so many people — it would be like the credits rolling at the end of a movie”), and the scandal in the stem-cell field that had threatened to derail the project earlier in the year. “It was like a sacred hour,” she says. Takahashi had been trying to use stem cells to repair retinal damage for ten years — and trying to downplay hype about the cells for almost as long. Her work received a boost when, in 2006, stem-cell scientist Shinya Yamanaka at Kyoto University in Japan discovered how to make iPS cells, which are much easier to make than other human pluripotent cells. Collaborating with Yamanaka, Takahashi worked out how to turn the iPS cells into sheets of retinal epithelial cells. She then tested the resulting cells in mice and monkeys, passed regulatory hurdles, recruited patients, and practised growing cells from those patients. Finally, she was ready to try the transplants in people with a common condition called age-related macular degeneration, in which wayward blood vessels destroy photoreceptors and vision. The transplants are meant to cover the retina, patch up the epithelial layer and support the remaining photoreceptors. Watching the procedure, “I could feel the tension of the surgeon”, Takahashi says. In the end, everything went smoothly — but Takahashi will not reveal whether it has been a success until a year after the transplant. She does say that the tissue seems to have maintained its brownish colour, a sign that it has not been attacked by the immune system. The patient, a woman in her 70s, had already lost most of her vision and is unlikely to get it back; but Takahashi's team is keen to see whether the transplant is safe and prevents further retinal deterioration. Takahashi had planned to operate on six patients in an informal clinical study. But a law that went into effect in Japan last month opens the door to a fast-track formal trial that would move the technology, if successful, to open clinical use. She is now considering which path to take.The transplant was a high point for the field after a major low. Earlier in the year, controversy over two stem-cell papers published in Nature and unrelated to Takahashi's research had enveloped the CDB. The papers, which reported a quick recipe for making pluripotent stem cells, were first lauded and then shunned after it emerged that some figures had been manipulated. The spotlight fell on Haruko Obokata, the papers' first author, who continued to argue that the method worked. The episode took a tragic turn when Yoshiki Sasai, who supervised Obokata at the CDB, killed himself in August. In the wake of the scandal, the centre was drastically restructured and its research budget was slashed.As all this unfolded, Takahashi found her own work under intense scrutiny: she was accused of rushing the procedure in an effort to make money, and concerns were raised over whether the cells were safe. A month before the scheduled surgery, the health ministry suddenly announced that several new safety tests would be required. At times, Takahashi says, she felt “beaten”.Now upbeat, however, Takahashi is aiming to clear a much higher bar — transplanting layers of photoreceptors together with the epithelial sheets — to restore a small degree of vision to people with macular degeneration. The photoreceptors would have to make connections with neurons, something that Takahashi realizes will be a challenge. For that, she will use the ability to grow three-dimensional retinal tissue in vitro — a technique, she notes with sadness, that was pioneered by Sasai.Other scientists at the centre share the grief, and say that Takahashi's success was a welcome distraction. “It was definitely encouraging for all CDB people,” says developmental biologist Masatoshi Takeichi, former director of the centre.
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