Literature DB >> 31838378

Hadassah, provider of "Regulatory-Ready" pluripotent clinical-grade stem cell banks.

Shelly E Tannenbaum1, Orna Singer2, Yaniv Gil3, Yael Berman-Zaken4, Nili Ilouz5, Hanita Khaner6, Miriam Haimov7, Benjamin E Reubinoff8.   

Abstract

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.
Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.

Entities:  

Keywords:  Biosafety testing; Certificate of analysis; Clinical-grade hESC lines; Disease-affected hESC lines; QC testing; Transplantation therapy; Xeno-free

Mesh:

Year:  2019        PMID: 31838378     DOI: 10.1016/j.scr.2019.101670

Source DB:  PubMed          Journal:  Stem Cell Res        ISSN: 1873-5061            Impact factor:   2.020


  2 in total

1.  Perspectives on the cost of goods for hPSC banks for manufacture of cell therapies.

Authors:  Jung-Hyun Kim; Eihachiro Kawase; Kapil Bharti; Ohad Karnieli; Yuji Arakawa; Glyn Stacey
Journal:  NPJ Regen Med       Date:  2022-09-29

2.  Different transcriptional profiles of human embryonic stem cells grown in a feeder-free culture system and on human foreskin fibroblast feeder layers.

Authors:  Lu Xiao; Juan Zhu; Zheng Liu; Bangyong Wu; Xiaohua Zhou; Yanxing Wei; Fei Sun; Zhijian Wang; Song Quan; Qi Li; Jun Wang; Liping Huang; Yanlin Ma
Journal:  Aging (Albany NY)       Date:  2022-09-13       Impact factor: 5.955

  2 in total

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