References 參考資料： [1] Perrin, Steve. “Preclinical research: Make mouse studies work.” Nature, vol. 507, no. 7493, 2014, pp. 423–425. https://doi.org/10.1038/507423a. [2] Clevers, Hans. “Hans Clevers (Hubrecht I., UU) 1: Discovery and Characterization of Adult Stem Cells in the Gut.” Youtube, uploaded by Science Communication Lab, 19 February 2020, https://www. youtube.com/watch?v=HgVivkoA7UA. [3] Barker, Nick, et al. “Identification of stem cells in small intestine and colon by marker gene Lgr5.” Nature, vol. 449, no. 7165, 2007, pp. 1003–1007. https://doi. org/10.1038/nature06196. [4] Paré, Jean-François, and James L. Sherley. “Biological Principles for Ex Vivo Adult Stem Cell Expansion.” Current Topics in Developmental Biology, vol. 73, 2006, pp. 141–171. https://doi.org/10.1016/S0070-2153(05)730052. [5] Simian, Marina, and Mina. J. Bissell. “ Organoids: A historical perspective of thinking in three dimensions.” Journal of Cell Biology, vol. 216, no. 1, 2017, pp. 31–40. https://doi.org/10.1083/jcb.201610056. [6] Corrò, Claudia, et al. “A brief history of organoids.” American Journal of Physiology: Cell Physiology, vol. 319, no. 1, 2020, pp. C151–C165. https://doi.org/10.1152/ ajpcell.00120.2020. [7] Yui, Shiro, et al. “Functional engraftment of colon epithelium expanded in vitro from a single adult Lgr5+ stem cell.” Nature Medicine, vol. 18, no. 4, 2012, pp. 618–623. https://doi.org/10.1038/nm.2695. [8] Wang, Shusen, et al. “Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient.” Cell, vol. 187, no. 22, 2024, pp. 6152–6164.e18. https://doi.org/10.1016/j.cell.2024.09.004. [9] Kim, Jihoon, et al. “Human organoids: model systems for human biology and medicine.” Nature Reviews Molecular Cell Biology, vol. 21, no. 10, 2020, pp. 571– 584. https://doi.org/10.1038/s41580-020-0259-3. [10] Zimmer, Carl. “What We Can Learn From Brain Organoids.” The New York Times, 8 Nov. 2025, https:// www.nytimes.com/2025/11/06/science/brainorganoids-neurons.html. [11] “S.5002 – 117th Congress (2021-2022): FDA Modernization Act 2.0.” Congress.gov, 2022, https:// www.congress.gov/bill/117th-congress/senate-bill/5002. [12] “FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs.” U.S. Food and Drug Administration, 10 Apr. 2025, https://www.fda.gov/news-events/pressannouncements/fda-announces-plan-phase-outanimal-testing-requirement-monoclonal-antibodiesand-other-drugs. 類器官能大幅縮短過程，讓科學家快速建立疾病模型。 在腦類器官的研究中，科學家已利用來自患者的類器官 模擬阿茲海默症和柏金遜症 [6]。 也許另一個更令人振奮的類器官應用是藥物篩選。 一直以來，臨床試驗前對藥物毒性評估不佳，是許多新 藥研發失敗的主因 [6]。這點在癌症藥物中尤為明顯， 因為這類療法可能帶來嚴重，甚至致命的副作用。為此， 研究人員透過比較源自同一患者的正常細胞和癌細胞 所培育出的類器官對藥物的反應，就能更準確地評估藥 物的功效和毒性 [6]。 再見實驗老鼠？ 最後這一切到底意味著甚麼？類器官會終結「白老 鼠」的時代嗎？目前還不會。模式生物在科學界仍有獨特 價值，由於已有大量研究成果和成熟的實驗技術，動物 模型提供了成本較低的方法進行基礎研究 [9]。雖然類 器官在精準治療和再生醫學中的潛力已廣受認可，但這 個領域仍處於起步階段，前方還有重大的技術瓶頸，臨 床成果也相當有限。儘管如此，隨著美國通過《食品藥 物管理局（FDA）現代化法案 2.0》，監管上的進程得以 推進，因為法案授權使用類器官和人工智慧電腦模型等 「嶄新方法」，取代新藥臨床試驗申請所需的強制動物 測試 [11, 12]。這使新藥能以更有效，更能模擬人體反 應的方式進行測試 [12]。2025年4月，FDA進一步宣 布了在未來三至五年逐步淘汰動物實驗的路線圖 [11]。 如此看來，可能在不久之後，至少在臨床試驗中，我們將 能與實驗老鼠說再見。
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