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FDA批准脐带血制品

2011-11-28 MedSci原创 MedSci原创

  11月10日,美国FDA批准第一个特许脐带造血祖细胞(HPC-C)——HEMACORD细胞疗法。HEMACORD适用于有造血系统疾病患者的造血干细胞移植。例如,脐带血移植已用于治疗某些血癌、某些遗传代谢和免疫系统疾病。   HEMACORD含有来自人脐带血的造血祖细胞(HPCs)。脐带血是用于移植HPCs的3个来源之一,其他2个来源是骨髓和外周血。一旦这些 HPCs被输入病人体内,移行至骨髓

  11月10日,美国FDA批准第一个特许脐带造血祖细胞(HPC-C)——HEMACORD细胞疗法。HEMACORD适用于有造血系统疾病患者的造血干细胞移植。例如,脐带血移植已用于治疗某些血癌、某些遗传代谢和免疫系统疾病。

  HEMACORD含有来自人脐带血的造血祖细胞(HPCs)。脐带血是用于移植HPCs的3个来源之一,其他2个来源是骨髓和外周血。一旦这些 HPCs被输入病人体内,移行至骨髓,在骨髓中分裂和发育成熟。当这些成熟细胞进入血流就能部分地或完全地恢复多种血细胞的数量和功能,包括免疫功能。

  FDA告诫,HEMACORD的加框警告涉及有关发生移植物抗宿主病(GVHD)、移植物移入综合征、移植物失功和输注反应的危险,上述每种危险都可能是致命的。对接受HEMACORD的病人应小心监测。有关HEMACORD的风险获益评估、单位选择和给药,应听从有造血干细胞移植经验的医师指导。

  英文链接:FDA approves first cord blood product

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    2012-03-15 bugit
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