{"id":1501,"date":"2022-07-29T10:41:00","date_gmt":"2022-07-29T02:41:00","guid":{"rendered":"https:\/\/vcro.online\/wordpress4\/?p=1501"},"modified":"2024-08-29T15:41:19","modified_gmt":"2024-08-29T07:41:19","slug":"cell-free-therapy-the-chance-and-the-challenge-%e3%80%8c%e4%b8%8d%e5%90%ab%e7%b4%b0%e8%83%9e%e7%9a%84%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82%e7%94%a2%e5%93%81%e3%80%8d%ef%bc%9a%e6%a9%9f%e6%9c%83","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1501","title":{"rendered":"Cell-free therapy: the chance and the challenge 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therapy)\u300d\u662f\u6307\u4f7f\u7528\u6e90\u81ea\u65bc\u7d30\u80de\u7684\u6210\u5206\u4e26\u907f\u514d\u76f4\u63a5\u4f7f\u7528\u6d3b\u7d30\u80de\u7684\u6cbb\u7642\u7b56\u7565\u4ee5\u63d0\u4f9b\u66f4\u5b89\u5168\u7684\u65b9\u6cd5\u4f86\u6cbb\u7642\u6216\u9810\u9632\u75be\u75c5\u9032\u5c55\u3002\u96d6\u7136\u751f\u9577\u56e0\u5b50\u6216\u7d30\u80de\u6fc0\u7d20\u7b49\u55ae\u4e00\u7d30\u80de\u4f86\u6e90\u7684\u56e0\u5b50\u65e9\u5df2\u6210\u70ba\u85e5\u7269\u6cbb\u7642\u7684\u9078\u9805\uff0c\u4f46\u5229\u7528\u65c1\u5206\u6ccc\u7cfb\u7d71(paracrine secretion system)\u6240\u8a2d\u8a08\u7684\u7522\u54c1\u4f3c\u4e4e\u66f4\u63a5\u8fd1\u6b63\u5e38\u7d44\u7e54\u7684\u751f\u7406\u4fee\u5fa9\u6a5f\u5236\u3002\u65c1\u5206\u6ccc\u7684\u4e00\u500b\u95dc\u9375\u7d44\u6210\u90e8\u5206\u662f\u7d30\u80de\u5916\u56ca\u6ce1 (extracellular 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MutationTest v2\u3001Epi proColon<sup>\u00ae<\/sup>\u4ee5\u53caGuardant360<sup>\u00ae<\/sup>&nbsp;CDx\uff1b\u4f46\u81f3\u4ecaFDA\u5c1a\u672a\u6838\u51c6\u4efb\u4f55\u5916\u6ccc\u9ad4\u6cbb\u7642\u7522\u54c1\uff0c\u4e5f\u672a\u9812\u5e03\u8207CMC\u6216\u524d\u81e8\u5e8a\u8a66\u9a57\u76f8\u95dc\u7684\u6cd5\u898f\u6307\u5357\u3002\u4ee5\u7f8e\u570b\u6cd5\u898f\u800c\u8a00\uff0c\u5916\u6ccc\u9ad4\u7522\u54c1\u4e43\u5c6c\u65bcPHS Act Section 351\u6240\u898f\u7bc4\u7684\u4eba\u9ad4\u7d30\u80de\u7d44\u7e54\u7522\u54c1(HCT\/P)\uff0c\u7531FDA \u7684\u751f\u7269\u88fd\u54c1\u8a55\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3(Center for Biologics Evaluation and Research, CBER)\u6240\u4e0b\u8f44\u7684\u7d44\u7e54\u548c\u9ad8\u7d1a\u7642\u6cd5\u8fa6\u516c\u5ba4 (Office of Tissues and Advanced Therapies, OTAT)\u8ca0\u8cac\u7ba1\u7406\u3002\u5c31\u73fe\u6709\u7684\u88fd\u85e5\u5de5\u85dd\uff0c\u96d6\u7136\u6709\u6548\u5206\u96e2\u548c\u7d14\u5316\u5916\u6ccc\u9ad4\u78ba\u5be6\u4ecd\u6709\u8a31\u591a\u6280\u8853\u4e0a\u7684\u9650\u5236\u56f0\u96e3\uff0c\u4e0d\u904e\u8a31\u591a\u7522\u54c1\u5df2\u7d93\u5728\u8655\u65bc\u81e8\u5e8a\u524d\u7814\u7a76\u6216\u5df2\u9032\u5165\u65e9\u671f\u81e8\u5e8a\u8a66\u9a57\u968e\u6bb5\u4e26\u53d6\u5f97\u4e00\u5b9a\u6210\u679c\u3002\u7136\u800c\uff0c\u5982\u524d\u8ff0\u6240\u8a00\uff0c\u76ee\u524d\u7531\u65bc\u5916\u6ccc\u9ad4\u7684\u6536\u96c6\u3001\u5206\u96e2\u548c\u5206\u6790\u65b9\u6cd5\u7684\u9ad8\u5ea6\u4e0d\u4e00\u81f4\uff0c\u9019\u4e9b\u7570\u8cea\u6027\u5c0d\u65bc\u6b64\u9818\u57df\u767c\u5c55\u4e5f\u9020\u6210\u4e86\u91cd\u5927\u969c\u7919\u3002\u70ba\u4e86\u89e3\u6c7a\u9019\u4e9b\u554f\u984c\uff0c\u570b\u969b\u7d30\u80de\u5916\u56ca\u6ce1\u5b78\u6703 (ISEV) 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N Engl J Med. 2017 Mar 16;376(11):1007-1009<br>2. 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