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美国FDA于2011年11月10日核发给纽约血液中心(NYBC)的脐带血造血祖细胞HEMACORD ( hematopoietic stem/progenitor cells) 了生物制品许可(biologics license application；BLA125397)，用于异基因造血干细胞移植，治疗遗传性或获得性造血系统疾病患者，成为FDA批准第一个的干细胞产品，该许可再次掀起那场关于这类产品是否需要附加规定长期的争论。英国达勒姆大学罗莱纳脐血库主任Joanne Kurtzberg主任说：“说来话长，还不清楚这份许可的预期效果”，预示FDA将进一步调节外周血来源造血干细胞疗法相关规定。
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Nature Biotechnology | News / h" j/ }" }( e; O! ], f9 o
Hemacord approval may foreshadow regulatory creep for HSC therapies
# D- m1 l1 e4 g. E; U) P' tMalorye Allison1 Journal name:Nature Biotechnology Volume:30,Page:304Year published 2012) doi:10.1038/nbt0412-304 Published online10 April 2012 Article toolsPrint9 p. z. b! `7 u: V
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Cells isolated from human cord blood now require a license.. }9 }6 H" d' n! r& b
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7 o' J6 P& K& J8 P0 H% h0 uThe first license for a cord blood product has been granted to the New York Blood Center (NYBC) for Hemacord, hematopoietic stem/progenitor cells (HSCs) isolated from human cord blood for use in allogeneic transplantation in certain blood disorders or malignancies. The approval has reignited a long-simmering debate over whether such products need additional regulation. “This has been a very long story, and it's not clear that this [license] will have the intended effect,” says Joanne Kurtzberg, director of Carolinas Cord Bank, and the Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, Durham, North Carolina. There is also concern that the US Food and Drug Administration (FDA) will now move to further regulate HSC therapies derived from peripheral blood.
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Hemacord (BLA125397)
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FDA批准首个脐带血造血祖细胞制品 http://www.stemcell8.cn/thread-48960-1-1.html
9 E0 @6 d. p! a$ ?) jFDA关于HEMACORD脐带血造血祖细胞制品的CTGTAC Briefing Document http://www.stemcell8.cn/thread-49252-1-1.html
2 g3 Q4 v9 F5 e1 n) c8 d5 xHEMACORD脐带血造血祖细胞制品使用说明书 http://www.stemcell8.cn/thread-48956-1-1.html
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发表于 2012-4-17 22:14
发表于 2012-4-18 06:28
