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临床级人胚胎干细胞系RCe015-A(RC-11)的衍生

Derivation of the clinical grade human embryonic stem cell line RCe015-A (RC-11).

作者信息

De Sousa P A, Tye B J, Bruce K, Dand P, Russell G, Collins D M, Greenshields A, McDonald K, Bradburn H, Laurie A, Canham M, Kunath T, Downie J M, Bateman M, Courtney A

机构信息

Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK; Centre for Clinical Brain Sciences, University of Edinburgh, UK; MRC Centre for Regenerative Medicine, University of Edinburgh, UK.

Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK.

出版信息

Stem Cell Res. 2016 Jul;17(1):42-48. doi: 10.1016/j.scr.2016.04.021. Epub 2016 May 7.

Abstract

The human embryonic stem cell line RCe015-A (RC-11) was derived under quality assured compliance with UK regulation, European Union Directives and International guidance for tissue procurement, processing and storage according to Good Manufacturing Practice (GMP) standards. The cell line was derived from a fragmented cleavage stage embryo voluntarily donated as unsuitable or surplus to fertility requirements following informed consent. RCe015-A (RC-11) shows normal pluripotency marker expression and differentiation to the three germ layers in vitro and in vivo. It has a normal 46XX female karyotype and microsatellite PCR identity, HLA and blood group typing data are available.

摘要

人类胚胎干细胞系RCe015 - A(RC - 11)是依据英国法规、欧盟指令以及国际组织关于组织采购、处理和储存的指导方针,并按照药品生产质量管理规范(GMP)标准,在质量保证的前提下建立的。该细胞系源自一个处于卵裂期的碎片化胚胎,此胚胎是在获得知情同意后,因不适合或超出生育需求而自愿捐赠的。RCe015 - A(RC - 11)在体外和体内均表现出正常的多能性标志物表达,并能分化形成三个胚层。它具有正常的46XX女性核型,有微卫星PCR鉴定结果,且可获取HLA和血型分型数据。

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