法學期刊
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論著名稱:
國內細胞治療的現況、限制與風險(Current Situations, Limitations, and Risks of Cell Therapy in Taiwan)
文獻引用
編著譯者: 何弘能
出版日期: 2022.05
刊登出處: 台灣/醫療品質雜誌第 16 卷 第 3 期/72-75 頁
頁  數: 4 點閱次數: 305
下載點數: 16 點 銷售明細: 權利金查詢 變更售價
授 權 者: 財團法人醫院評鑑暨醫療品質策進會 授權者指定不分配權利金給作者)
關 鍵 詞: 細胞治療再生醫療未被滿足的醫療需求再生醫療三法特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法誘導性多功能幹細胞
中文摘要: 隨著醫療科技的快速突破,細胞或基因改造過的細胞治療、再生醫療可解決許多未被滿足的醫療需求,再加上商機無限,已成為近 10 年進展最快的一種治療方向。細胞治療具有許多限制及挑戰,從研發、製備場所、供應、臨床試驗、治療到追蹤,皆與藥物管理有很大差異,無法依相同法規或規範執行。而法規齊備、專業人才培育與延攬、降低費用及結合AI科技等,都是細胞治療成功的關鍵。如何讓有需求的病人能順利、安心的接受治療,而不只是「富人醫療」,是我們最大且重要的期望及目標。
英文關鍵詞: cell therapyregenerative medicineunmet medical needsthree acts related to regenerative medicineRegulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devicesinduced pluripotent stem cells (iPSC)
英文摘要: As medical technology advances rapidly, cell therapy and regenerative medicine involving cells or genetically-modified cells can address many unmet medical needs. They have infinite commercial opportunities and have become the one of the most rapidly developing directions for therapy in the last decade. Cell therapy is under various limitations and faces numerous challenges. The research and development, preparation sites, supplies, clinical trials, treatments, and follow-up procedures of cell therapy differ greatly from medicine management; thus, the regulations or norms for medicine management cannot be applied to cell therapy. The keys to successful cell therapy include comprehensive legislation, cultivation and recruitment of professionals, cost reduction, and integration with artificial intelligence technologies. To enable patients in need to smoothly receive cell therapy at ease, making cell therapy affordable to all people is our primary and most critical expectation and goal.
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相關論著:
何弘能,國內細胞治療的現況、限制與風險,醫療品質雜誌,第 16 卷 第 3 期,72-75 頁,2022年05月。
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