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\n\t\t\t\t\t\t\t\u76ee\u524d\u5df2\u4e0a\u5e02MSC\u6cbb\u7597\u4ea7\u54c1\u7684\u4f01\u4e1a[11]\uff0c\u5176\u751f\u4ea7\u6a21\u5f0f\u4ee5\u7ec6\u80de\u5de5\u5382\u57f9\u517b\u65b9\u5f0f\u4e3a\u4e3b\uff0c\u540c\u6b65\u8fdb\u884c\u751f\u7269\u53cd\u5e94\u5668\u7684\u751f\u4ea7\u5de5\u827a\u5f00\u53d1\u3002\u5982\u8fd1\u671f\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684Ryoncil(remestemcel-L-rknd)\uff0c\u4e3a\u540c\u79cd\u5f02\u4f53BM-MSC\u7597\u6cd5\uff0c\u7528\u4ee5\u6cbb\u7597\u7528\u4e8e\u6cbb\u75972\u4e2a\u6708\u53ca\u4ee5\u4e0a\u513f\u7ae5\u60a3\u8005\u7684\u7c7b\u56fa\u9187\u96be\u6cbb\u6027\u6025\u6027\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5(SR-aGVHD)\uff0c\u5176\u516c\u53f8Mesoblast\u5c31\u662f\u4f7f\u7528\u7ec6\u80de\u5de5\u5382\u8fdb\u884cRyoncil\u7684\u751f\u4ea7\uff08\u56fe1\uff09\uff0c\u540c\u65f6\u5e76\u884c\u5f00\u53d1\u5927\u89c4\u6a21\u7684\u751f\u7269\u53cd\u5e94\u5668\u57f9\u517b\u5de5\u827a[12]\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0cRyoncil\u7684\u751f\u4ea7\u662f\u59d4\u6258Lonza<\/span>\u8fdb\u884c\u7684[13, 14]\uff0c\u800cLonza\u7684GMP\u751f\u4ea7\u57fa\u5730\u5177\u6709\u4e00\u5957\u5b8c\u6210\u7684\u57fa\u4e8e\u7ec6\u80de\u5de5\u5382\u7684\u751f\u4ea7\u5382\u623f\u3002\u6b64\u5916\uff0c2015\u5e74\u5728\u65e5\u672c\u4e0a\u5e02\u7684TEMCELL\u00ae HS\uff08\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u4e0e\u513f\u7ae5\u7684aGVHD\uff09\uff0c\u4e5f\u662fMesoblast\u516c\u53f8\u6388\u6743JCR Pharmaceuticals\u7684\u4e00\u6b3eBM-MSC[15]\u3002\u5728\u5168\u7403\u5df2\u4e0a\u5e02\u768412\u6b3eMSC\u4ea7\u54c1\u4e2d[11]\uff0c\u9664\u4e86Mesoblast\u548cJCR Pharmaceuticals\u516c\u53f8\u4f7f\u7528\u7ec6\u80de\u5de5\u5382\u7684\u65b9\u5f0f\u751f\u4ea7MSC\u4ee5\u5916\uff0cStempeutics Research\u516c\u53f8\u7684Stempeucel\u660e\u786e\u4f7f\u752810\u5c42CellStack\uff08CN201080053627\uff09\u8fdb\u884c\u751f\u4ea7\uff0cMedipost\u516c\u53f8\u7684Cartistem[16]\u548cTakeda\u516c\u53f8\u7684Alofisel[17]\u4f7f\u7528\u7ec6\u80de\u5de5\u5382\u57f9\u517b\u7684\u65b9\u5f0f\u8fdb\u884c\u751f\u4ea7\u3002\u7531\u4e8eAnterogen\u516c\u53f8\u7684Queencell\u548cCupistem[18]\u3001Chiesi Farmaceutici\u516c\u53f8\u7684Holoclar\u3001Cell Tech Pharmed\u516c\u53f8\u7684MesestroCell\u3001Nipro Corp\u516c\u53f8\u7684Stemirac\u3001Corestem\u516c\u53f8\u7684NeuroNataR\u4ee5\u53caPharmicell\u516c\u53f8\u7684Cellgram AMI\u5747\u4e3a\u81ea\u4f53\u7ec4\u7ec7\u6765\u6e90\u7684MSC\uff0c\u6240\u4ee5\u65e0\u9700\u5927\u89c4\u6a21\u751f\u4ea7\uff0c\u4ec5\u5c0f\u89c4\u6a21\u8d34\u58c1\u57f9\u517b\u5373\u53ef\u3002<\/span>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\u7efc\u4e0a\u6240\u8ff0\uff0c\u5982\u4f55\u5229\u7528\u5df2\u6709\u7684\u7a33\u5b9a\u57f9\u517b\u65b9\u6848\uff08\u7ec6\u80de\u5de5\u5382\uff09\u9ad8\u6548\u751f\u4ea7\u6b65\u5165III\u671f\u4e34\u5e8a\u7684MSC\u4ea7\u54c1\uff0c\u5bf9\u65b0\u7684\u4ea7\u54c1\u7ba1\u7ebf\u540c\u6b65\u5f00\u53d1\u65b0\u7684\u57fa\u4e8e\u5fae\u8f7d\u4f53\u7684\u8d34\u58c1\u5de5\u827a\u6216\u65e0\u8f7d\u4f53\u7684\u60ac\u6d6e\u57f9\u517b\u5de5\u827a\u4ee5\u9002\u5e94\u672a\u6765\u7684\u5e02\u573a\u9700\u6c42\uff0c\u53ef\u80fd\u662f\u4e00\u79cd\u5408\u9002\u7684\u9009\u62e9\u3002<\/span>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\"\u56fe\u7247\"<\/span><\/span>\u56fe1 Ryoncil\u5728Lonza\u65b0\u52a0\u5761GMP\u5382\u623f\u4e2d\u751f\u4ea7<\/span>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t

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\n\t\t\t\t\t\t\tReferences<\/strong><\/span>\n\t\t\t\t\t\t<\/section>\n\t\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t
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\n\t\t\t[1] Levy, O., et al., Shattering barriers toward clinically meaningful MSC therapies. Sci Adv, 2020. 6(30): p. eaba6884.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[2] Baglio, S.R., D.M. Pegtel, and N. Baldini, Mesenchymal stem cell secreted vesicles provide novel opportunities in (stem) cell-free therapy. Front Physiol, 2012. 3: p. 359.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[3] Chen, B., et al., Stem Cell-Derived Extracellular Vesicles as a Novel Potential Therapeutic Tool for Tissue Repair. Stem Cells Transl Med, 2017. 6(9): p. 1753-1758.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[4] Claridge, B., et al., Development of Extracellular Vesicle Therapeutics: Challenges, Considerations, and Opportunities. Front Cell Dev Biol, 2021. 9: p. 734720.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[5] Gy\u00f6rgy, B., et al., Therapeutic applications of extracellular vesicles: clinical promise and open questions. Annu Rev Pharmacol Toxicol, 2015. 55: p. 439-464.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[6] Lechanteur, C., et al., MSC Manufacturing for Academic Clinical Trials: From a Clinical-Grade to a Full GMP-Compliant Process. Cells, 2021. 10(6).<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[7] Tsai, A.C. and C.A. Pacak, Bioprocessing of Human Mesenchymal Stem Cells: From Planar Culture to Microcarrier-Based Bioreactors. Bioengineering (Basel), 2021. 8(7).<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[8] L\u00f3pez-Fern\u00e1ndez, A., et al., Comparability exercise of critical quality attributes of clinical-grade human mesenchymal stromal cells from the Wharton's jelly: single-use stirred tank bioreactors versus planar culture systems. Cytotherapy, 2024. 26(5): p. 418-426.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[9] Kurogi, H., et al., Umbilical cord derived mesenchymal stromal cells in microcarrier based industrial scale culture sustain the immune regulatory functions. Biotechnol J, 2021. 16(6): p. e2000558.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[10] Kusuma, G.D., et al., Effect of 2D and 3D Culture Microenvironments on Mesenchymal Stem Cell-Derived Extracellular Vesicles Potencies. Front Cell Dev Biol, 2022. 10: p. 819726.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[11] Fern\u00e1ndez-Garza, L.E., S.A. Barrera-Barrera, and H.A. Barrera-Salda\u00f1a, Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals (Basel), 2023. 16(9).<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[12] Manufacturing – Mesoblast Ltd. Available from: <\/span>\n\t\t<\/p>\n\t\t

\n\t\t\thttps:\/\/mesoblast.com\/science\/manufacturing.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[13] CellBio Services | Lonza. Available from: <\/span>\n\t\t<\/p>\n\t\t

\n\t\t\thttps:\/\/bioscience.lonza.com\/lonza_bs\/CN\/en\/cellbio-services-custom-research.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[14]Mesoblast_Corporate_Overview_June_2020.Available from: <\/span>\n\t\t<\/p>\n\t\t

\n\t\t\thttps:\/\/mesoblast.com\/images\/Mesoblast_Corporate_Overview_June_2020.pdf.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[15] JCR Pharma launch TEMCELL\u00ae HS in Japan \u2022 Biopharma Asia. Available from: <\/span>\n\t\t<\/p>\n\t\t

\n\t\t\thttps:\/\/biopharma-asia.com\/sections\/jcr-pharma-launch-temcell-hs-in-japan\/.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[16] GMP Center \u2013 MEDIPOST. Available from: <\/span>\n\t\t<\/p>\n\t\t

\n\t\t\thttps:\/\/en.medi-post.co.kr\/gmp\/.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[17] de la Portilla, F., et al., Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease: results from a multicenter phase I\/IIa clinical trial. Int J Colorectal Dis, 2013. 28(3): p. 313-23.<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t[18] (Cell therapy products) ANTEROGEN. Available from: <\/span>\n\t\t<\/p>\n\t\t

\n\t\t\thttps:\/\/www.mfds.go.kr\/eng\/brd\/m_30\/view.do?seq=71337.<\/span>\n\t\t<\/p>\n\t<\/section>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

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