{"id":1514,"date":"2022-07-29T11:03:00","date_gmt":"2022-07-29T03:03:00","guid":{"rendered":"https:\/\/vcro.online\/cn\/?p=1514"},"modified":"2024-07-12T13:37:49","modified_gmt":"2024-07-12T05:37:49","slug":"cell-free-therapy-the-chance-and-the-challenge-%e3%80%8c%e4%b8%8d%e5%90%ab%e7%bb%86%e8%83%9e%e7%9a%84%e7%bb%86%e8%83%9e%e6%b2%bb%e7%96%97%e4%ba%a7%e5%93%81%e3%80%8d%ef%bc%9a%e6%9c%ba%e4%bc%9a","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1514","title":{"rendered":"Cell-free therapy: the chance and the challenge \u300c\u4e0d\u542b\u7ec6\u80de\u7684\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u300d\uff1a\u673a\u4f1a\u4e0e\u6311\u6218"},"content":{"rendered":"<figure class=\"wp-block-post-featured-image\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2022\/07\/891e1396-c1ba-4d77-aaf2-ca431175a66d.jpg\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"\" style=\"object-fit:cover;\" srcset=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2022\/07\/891e1396-c1ba-4d77-aaf2-ca431175a66d.jpg 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2022\/07\/891e1396-c1ba-4d77-aaf2-ca431175a66d-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2022\/07\/891e1396-c1ba-4d77-aaf2-ca431175a66d-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2022\/07\/891e1396-c1ba-4d77-aaf2-ca431175a66d-768x768.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n<p><strong>Cell-free therapy: the chance and the challenge<\/strong><br><strong>\u300c\u4e0d\u542b\u7ec6\u80de\u7684\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u300d\uff1a\u673a\u4f1a\u4e0e\u6311\u6218<\/strong><br>\u5373\u4fbf\u7ec6\u80de\u6cbb\u7597\u5df2\u53d1\u5c55\u8d85\u8fc720\u5e74\uff0c\u4f46FDA\u7684\u4e13\u5bb6\u4ecd\u8ba4\u4e3a\u5e72\u7ec6\u80de\u79fb\u690d\u6cbb\u7597\u4e4b\u6574\u4f53\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4ecd\u672a\u5f97\u5230\u8bc1\u5b9e<sup>1<\/sup>\u3002\u6545\u8fd1\u5e74\u6765\uff0c\u7ec6\u80de\u884d\u751f\u4ea7\u54c1\u6210\u4e3a\u65b0\u5174\u7684\u7814\u7a76\u70ed\u70b9\uff1b\u8fd9\u4e9b\u300c\u4e0d\u542b\u7ec6\u80de\u7684\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1(cell-free cellular therapy)\u300d\u662f\u6307\u4f7f\u7528\u6e90\u81ea\u4e8e\u7ec6\u80de\u7684\u6210\u5206\u5e76\u907f\u514d\u76f4\u63a5\u4f7f\u7528\u6d3b\u7ec6\u80de\u7684\u6cbb\u7597\u7b56\u7565\u4ee5\u63d0\u4f9b\u66f4\u5b89\u5168\u7684\u65b9\u6cd5\u6765\u6cbb\u7597\u6216\u9884\u9632\u75be\u75c5\u8fdb\u5c55\u3002\u867d\u7136\u751f\u957f\u56e0\u5b50\u6216\u7ec6\u80de\u6fc0\u7d20\u7b49\u5355\u4e00\u7ec6\u80de\u6765\u6e90\u7684\u56e0\u5b50\u65e9\u5df2\u6210\u4e3a\u836f\u7269\u6cbb\u7597\u7684\u9009\u9879\uff0c\u4f46\u5229\u7528\u65c1\u5206\u6ccc\u7cfb\u7edf(paracrine secretion system)\u6240\u8bbe\u8ba1\u7684\u4ea7\u54c1\u4f3c\u4e4e\u66f4\u63a5\u8fd1\u6b63\u5e38\u7ec4\u7ec7\u7684\u751f\u7406\u4fee\u590d\u673a\u5236\u3002\u65c1\u5206\u6ccc\u7684\u4e00\u4e2a\u5173\u952e\u7ec4\u6210\u90e8\u5206\u662f\u7ec6\u80de\u5916\u56ca\u6ce1 (extracellular vesicles)\u7684\u5916\u6ccc\u4f53(exosome)\uff0c\u5176\u4e2d\u7684\u751f\u957f\u56e0\u5b50\u3001\u7ed3\u6784\u86cb\u767d\u3001\u7ec6\u80de\u6fc0\u7d20\u7b49\u590d\u5408\u86cb\u767d\u8d28\u53ef\u5728\u635f\u4f24\u7ec6\u80de\u7ec4\u7ec7\u4e4b\u95f4\u6c34\u5e73\u8f6c\u79fb\u3002\u57fa\u4e8e\u5916\u6ccc\u4f53\u6216\u662f\u7ec6\u80de\u57f9\u517b\u57fa\u8d28(conditioned medium)\u53ef\u6bd4\u62df\u7ec6\u80de\u6cbb\u7597\u7684\u836f\u7406\u673a\u8f6c\uff0c\u56e0\u6b64\u8fd9\u4e9b\u9ad8\u9636\u7597\u6cd5\u4e5f\u6210\u4e3a\u518d\u751f\u533b\u5b66\u7684\u65b0\u53d1\u5c55\u7b56\u7565\u3002<br>\u00a0<br><strong>\u518d\u751f\u533b\u5b662.0<\/strong><br>\u4ee5\u76ee\u524d\u7684\u7814\u7a76\u7ed3\u679c\u6765\u770b\uff0c\u4f20\u7edf\u7ec6\u80de\u751f\u7269\u5b66\u6240\u63a8\u8bba\u5e72\u7ec6\u80de\u80fd\u53d1\u6325\u5176\u518d\u751f\u4f5c\u7528\u8fdb\u884c\u7ec6\u80de\/\u7ec4\u7ec7\u53d6\u4ee3\u7684\u5047\u8bbe\u662f\u4e0d\u5207\u5b9e\u9645\u7684\u3002\u79fb\u690d\u7684\u5916\u6e90\u6027\u5e72\u7ec6\u80de\u5e76\u4e0d\u4f1a\u5728\u60a3\u8005\u4f53\u5185\u5b58\u6d3b\u592a\u4e45\u4ee5\u5206\u5316\u5e76\u53d6\u4ee3\u53d7\u635f\u7ec6\u80de\uff1b\u5927\u591a\u6570\u7684\u5916\u6e90\u6027\u79fb\u690d\u7ec6\u80de\u90fd\u4f1a\u57287\u81f314\u5929\u5185\u88ab\u6e05\u9664\u3002\u6545\u5e72\u7ec6\u80de\u6240\u91ca\u653e\u5916\u6ccc\u4f53\u6216\u7ec6\u80de\u57f9\u517b\u57fa\u8d28\uff0c\u800c\u975e\u7ec6\u80de\u672c\u8eab\uff0c\u4fbf\u6210\u4e3a\u8ffd\u6c42\u518d\u751f\u533b\u5b66\u7684\u65b0\u65b9\u5411\u3002\u5176\u4e2d\uff0c\u5916\u6ccc\u4f53\u5bf9\u4e8e\u5305\u62ec\u80bf\u7624\u3001\u795e\u7ecf\u9000\u5316\u6027\u75be\u75c5\u3001\u5fc3\u8840\u7ba1\u75be\u75c5\u3001\u4f24\u53e3\u4fee\u590d\u5747\u5728\u52a8\u7269\u8bd5\u9a8c\u4e2d\u5c55\u73b0\u6f5c\u5728\u7597\u6548\u3002\u5916\u6ccc\u4f53\u4ea6\u53ef\u7ed3\u5408\u57fa\u56e0\u6cbb\u7597\u4f5c\u4e3a\u836f\u7269\u9012\u9001\u8f7d\u4f53\u7cfb\u7edf\u3002\u6b64\u5916\uff0c\u5916\u6ccc\u4f53\u7597\u6cd5\u53ef\u907f\u514d\u4f20\u7edf\u7ec6\u80de\u6cbb\u7597\u6240\u5f15\u53d1\u7684\u5b89\u5168\u6027\u95ee\u9898\uff0c\u540c\u65f6\u4fdd\u6709\u5e72\u7ec6\u80de\u7684\u514d\u75ab\u8c03\u8282\u3001\u7ec4\u7ec7\u4fee\u590d\u7b49\u6cbb\u7597\u80fd\u529b\u3002\u6709\u9274\u4e8e\u5916\u6ccc\u4f53\u4e0d\u4f1a\u8fdb\u884c\u590d\u5236\u3001\u4e0d\u8f6c\u5316\u4e3a\u6076\u6027\u7ec6\u80de\u6216\u5176\u4ed6\u6709\u5bb3\u7ec6\u80de\u7c7b\u578b\u3001\u4f4e\u514d\u75ab\u539f\u6d3b\u6027\u3001\u4ee5\u53ca\u5177\u8f83\u4f4e\u4f20\u64ad\u7279\u5b9a\u4f20\u67d3\u6027\u75be\u75c5\u7684\u98ce\u9669\uff0c\u56e0\u6b64\u5916\u6ccc\u4f53\u672c\u8d28\u4e0a\u6bd4\u6d3b\u7ec6\u80de\u79fb\u690d\u7684\u98ce\u9669\u66f4\u4f4e\u3002\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u4e5f\u6307\u51fa\u3002\u7531\u4e8e\u5916\u6ccc\u4f53\u6bd4\u6574\u4e2a\u7ec6\u80de\u5c0f\u5f97\u591a\uff0c\u53ef\u4ee5\u66f4\u5bb9\u6613\u5730\u5728\u4f53\u5185\u5faa\u73af\uff0c\u5230\u8fbe\u53d7\u4f24\u6216\u75be\u75c5\u90e8\u4f4d\u5e76\u89e6\u53d1\u6108\u5408\uff0c\u6545\u5916\u6ccc\u4f53\u4ea6\u5728\u795e\u7ecf\u9000\u5316\u6027\u75be\u75c5\u5c55\u73b0\u7597\u6548\u4f18\u52bf\u3002\u65e9\u671f\u7684\u5b66\u672f\u578b\u4e34\u5e8a\u8bd5\u9a8c\u5df2\u8bc1\u660e\u5916\u6ccc\u4f53\u7684\u6cbb\u7597\u6f5c\u529b\u4e0e\u5b89\u5168\u6027\u3002\u57282016\u5e74\u4e00\u9879\u5bf940\u540d\u665a\u671f\u6162\u6027\u80be\u810f\u75c5\u60a3\u8005\u6240\u8fdb\u884c\u7684\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c\u8868\u660e\uff1a\u4e0e\u5bf9\u7167\u7ec4\u76f8\u6bd4\uff0c\u63a5\u53d7\u5916\u6ccc\u4f53\u6cbb\u7597\u7684\u60a3\u8005\u5728\u6cbb\u7597\u540e12\u5468\u540e\u80be\u529f\u80fd\u663e\u8457\u63d0\u5347\uff0c\u5e76\u53ef\u53d1\u73b0\u5176\u8840\u6e05\u4e2d\u6291\u5236\u53d1\u708e\u7ec6\u80de\u6fc0\u7d20(\u5982TGF-\u03b21\u4ee5\u53caIL-10)\u663e\u8457\u63d0\u5347\u3002\u800c\u5728\u8bd5\u9a8c\u89c2\u5bdf\u671f\u95f4\u5185\u53ef\u53d1\u73b0\uff0c\u6cbb\u7597\u7ec4\u4e4b\u53d7\u8bd5\u8005\u672a\u51fa\u73b0\u4e0d\u826f\u4e8b\u4ef6<sup>2<\/sup>\uff0c\u663e\u793a\u8fd9\u6837\u7684\u65b0\u5174\u7597\u6cd5\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u53ca\u8010\u53d7\u6027\u53ca\u6f5c\u5728\u7597\u6548\u3002<br>\u00a0<br><strong>\u9006\u98ce\uff1a\u5916\u6ccc\u4f53\u4f5c\u4e3a\u836f\u7269\u7684\u969c\u788d<\/strong><br>\u867d\u7136\u76ee\u524d\u5df2\u6709\u6570\u4e2a\u85c9\u7531\u4fa6\u6d4b\u764c\u75c7\u7ec6\u80de\u7ec4\u7ec7\u5916\u6ccc\u4f53\u4ee5\u8f85\u52a9\u51b3\u5b9a\u6cbb\u7597\u65b9\u9488\u4e4b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u83b7\u5f97\u7f8e\u56fdFDA\u8bb8\u53ef(clearance)\u6216\u6838\u51c6(approval)\uff0c\u5982cobas<sup>\u00ae<\/sup>\u00a0EGFR MutationTest v2\u3001Epi proColon<sup>\u00ae<\/sup>\u4ee5\u53caGuardant360<sup>\u00ae<\/sup>\u00a0CDx\uff1b\u4f46\u81f3\u4ecaFDA\u5c1a\u672a\u6838\u51c6\u4efb\u4f55\u5916\u6ccc\u4f53\u6cbb\u7597\u4ea7\u54c1\uff0c\u4e5f\u672a\u9881\u5e03\u4e0eCMC\u6216\u524d\u4e34\u5e8a\u8bd5\u9a8c\u76f8\u5173\u7684\u6cd5\u89c4\u6307\u5357\u3002\u4ee5\u7f8e\u56fd\u6cd5\u89c4\u800c\u8a00\uff0c\u5916\u6ccc\u4f53\u4ea7\u54c1\u4e43\u5c5e\u4e8ePHS Act Section 351\u6240\u89c4\u8303\u7684\u4eba\u4f53\u7ec6\u80de\u7ec4\u7ec7\u4ea7\u54c1(HCT\/P)\uff0c\u7531FDA \u7684\u751f\u7269\u5236\u54c1\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3(Center for Biologics Evaluation and Research, CBER)\u6240\u4e0b\u8f96\u7684\u7ec4\u7ec7\u548c\u9ad8\u7ea7\u7597\u6cd5\u529e\u516c\u5ba4 (Office of Tissues and Advanced Therapies, OTAT)\u8d1f\u8d23\u7ba1\u7406\u3002\u5c31\u73b0\u6709\u7684\u5236\u836f\u5de5\u827a\uff0c\u867d\u7136\u6709\u6548\u5206\u79bb\u548c\u7eaf\u5316\u5916\u6ccc\u4f53\u786e\u5b9e\u4ecd\u6709\u8bb8\u591a\u6280\u672f\u4e0a\u7684\u9650\u5236\u56f0\u96be\uff0c\u4e0d\u8fc7\u8bb8\u591a\u4ea7\u54c1\u5df2\u7ecf\u5728\u5904\u4e8e\u4e34\u5e8a\u524d\u7814\u7a76\u6216\u5df2\u8fdb\u5165\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u5e76\u53d6\u5f97\u4e00\u5b9a\u6210\u679c\u3002\u7136\u800c\uff0c\u5982\u524d\u8ff0\u6240\u8a00\uff0c\u76ee\u524d\u7531\u4e8e\u5916\u6ccc\u4f53\u7684\u6536\u96c6\u3001\u5206\u79bb\u548c\u5206\u6790\u65b9\u6cd5\u7684\u9ad8\u5ea6\u4e0d\u4e00\u81f4\uff0c\u8fd9\u4e9b\u5f02\u8d28\u6027\u5bf9\u4e8e\u6b64\u9886\u57df\u53d1\u5c55\u4e5f\u9020\u6210\u4e86\u91cd\u5927\u969c\u788d\u3002\u4e3a\u4e86\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\uff0c\u56fd\u9645\u7ec6\u80de\u5916\u56ca\u6ce1\u5b66\u4f1a (ISEV) 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N Engl J Med. 2017 Mar 16;376(11):1007-1009<br>2. 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