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Hadassah, provider of "Regulatory-Ready" pluripotent clinical-grade stem cell banks.
Stem Cell Research ( IF 0.8 ) Pub Date : 2019-11-26 , DOI: 10.1016/j.scr.2019.101670
Shelly E Tannenbaum 1 , Orna Singer 1 , Yaniv Gil 1 , Yael Berman-Zaken 1 , Nili Ilouz 1 , Hanita Khaner 1 , Miriam Haimov 1 , Benjamin E Reubinoff 2
Affiliation  

The Hadassah hESC Research Center's aim is to be a supplier of clinical and research-grade human embryonic stem cell (hESC) lines. In 2012, we derived the first three entirely GMP-compliant and xeno-free, fully-characterised, feeder-dependent (human umbilical cord) hESC lines developed under cleanroom conditions. In 2018, we established four new GMP and xeno-free, feeder-independent MCB hESCs under GMP conditions using commercially available reagents, media and matrix. All cell lines were derived under Israeli Ministry of Health's National Ethics Committee for Genetic Research in Humans and the ethical considerations that guided the development of the hESCs strictly followed Israeli law. Hadassah has provided its clinical-grade hESC lines to commercial entities of which two are already in clinical trials, establishing Hadassah as a key provider of clinical-grade hESC lines.



中文翻译:

哈达萨(Hadassah),“监管就绪”的多能临床级干细胞库的提供者。

哈达萨hESC研究中心的目标是成为临床和研究级人类胚胎干细胞(hESC)系的供应商。2012年,我们获得了在洁净室条件下开发的前三条完全符合GMP标准且无异种,完全特征,与饲养者相关的(人类脐带)hESC系。在2018年,我们使用市售试剂,培养基和基质在GMP条件下建立了四种新的GMP和无异种,与饲养者无关的MCB hESC。所有细胞系均来自以色列卫生部国家人类基因研究国家伦理委员会,并且指导人类胚胎干细胞发展的伦理考虑严格遵循以色列法律。哈达萨(Hadassah)已向商业实体提供了其临床级hESC系列,其中两个实体已经在进行临床试验,

更新日期:2019-11-26
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