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Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications

Clinically compliant human embryonic stem cells (hESCs) should be developed in adherence to ethical standards, without risk of contamination by adventitious agents. Here we developed for the first time animal-component free and good manufacturing practice (GMP)-compliant hESCs. After vendor and raw...

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Autores principales: Tannenbaum, Shelly E., Tako Turetsky, Tikva, Singer, Orna, Aizenman, Einat, Kirshberg, Sophie, Ilouz, Nili, Gil, Yaniv, Berman-Zaken, Yael, Perlman, Temima Schnitzer, Geva, Nitshia, Levy, Ora, Arbell, Daniel, Simon, Alex, Ben-Meir, Assaf, Shufaro, Yoel, Laufer, Neri, Reubinoff, Benjamin E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380026/
https://www.ncbi.nlm.nih.gov/pubmed/22745653
http://dx.doi.org/10.1371/journal.pone.0035325
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author Tannenbaum, Shelly E.
Tako Turetsky, Tikva
Singer, Orna
Aizenman, Einat
Kirshberg, Sophie
Ilouz, Nili
Gil, Yaniv
Berman-Zaken, Yael
Perlman, Temima Schnitzer
Geva, Nitshia
Levy, Ora
Arbell, Daniel
Simon, Alex
Ben-Meir, Assaf
Shufaro, Yoel
Laufer, Neri
Reubinoff, Benjamin E.
author_facet Tannenbaum, Shelly E.
Tako Turetsky, Tikva
Singer, Orna
Aizenman, Einat
Kirshberg, Sophie
Ilouz, Nili
Gil, Yaniv
Berman-Zaken, Yael
Perlman, Temima Schnitzer
Geva, Nitshia
Levy, Ora
Arbell, Daniel
Simon, Alex
Ben-Meir, Assaf
Shufaro, Yoel
Laufer, Neri
Reubinoff, Benjamin E.
author_sort Tannenbaum, Shelly E.
collection PubMed
description Clinically compliant human embryonic stem cells (hESCs) should be developed in adherence to ethical standards, without risk of contamination by adventitious agents. Here we developed for the first time animal-component free and good manufacturing practice (GMP)-compliant hESCs. After vendor and raw material qualification, we derived xeno-free, GMP-grade feeders from umbilical cord tissue, and utilized them within a novel, xeno-free hESC culture system. We derived and characterized three hESC lines in adherence to regulations for embryo procurement, and good tissue, manufacturing and laboratory practices. To minimize freezing and thawing, we continuously expanded the lines from initial outgrowths and samples were cryopreserved as early stocks and banks. Batch release criteria included DNA-fingerprinting and HLA-typing for identity, characterization of pluripotency-associated marker expression, proliferation, karyotyping and differentiation in-vitro and in-vivo. These hESCs may be valuable for regenerative therapy. The ethical, scientific and regulatory methodology presented here may serve for development of additional clinical-grade hESCs.
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spelling pubmed-33800262012-06-28 Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications Tannenbaum, Shelly E. Tako Turetsky, Tikva Singer, Orna Aizenman, Einat Kirshberg, Sophie Ilouz, Nili Gil, Yaniv Berman-Zaken, Yael Perlman, Temima Schnitzer Geva, Nitshia Levy, Ora Arbell, Daniel Simon, Alex Ben-Meir, Assaf Shufaro, Yoel Laufer, Neri Reubinoff, Benjamin E. PLoS One Research Article Clinically compliant human embryonic stem cells (hESCs) should be developed in adherence to ethical standards, without risk of contamination by adventitious agents. Here we developed for the first time animal-component free and good manufacturing practice (GMP)-compliant hESCs. After vendor and raw material qualification, we derived xeno-free, GMP-grade feeders from umbilical cord tissue, and utilized them within a novel, xeno-free hESC culture system. We derived and characterized three hESC lines in adherence to regulations for embryo procurement, and good tissue, manufacturing and laboratory practices. To minimize freezing and thawing, we continuously expanded the lines from initial outgrowths and samples were cryopreserved as early stocks and banks. Batch release criteria included DNA-fingerprinting and HLA-typing for identity, characterization of pluripotency-associated marker expression, proliferation, karyotyping and differentiation in-vitro and in-vivo. These hESCs may be valuable for regenerative therapy. The ethical, scientific and regulatory methodology presented here may serve for development of additional clinical-grade hESCs. Public Library of Science 2012-06-20 /pmc/articles/PMC3380026/ /pubmed/22745653 http://dx.doi.org/10.1371/journal.pone.0035325 Text en Tannenbaum et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Tannenbaum, Shelly E.
Tako Turetsky, Tikva
Singer, Orna
Aizenman, Einat
Kirshberg, Sophie
Ilouz, Nili
Gil, Yaniv
Berman-Zaken, Yael
Perlman, Temima Schnitzer
Geva, Nitshia
Levy, Ora
Arbell, Daniel
Simon, Alex
Ben-Meir, Assaf
Shufaro, Yoel
Laufer, Neri
Reubinoff, Benjamin E.
Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications
title Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications
title_full Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications
title_fullStr Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications
title_full_unstemmed Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications
title_short Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications
title_sort derivation of xeno-free and gmp-grade human embryonic stem cells – platforms for future clinical applications
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380026/
https://www.ncbi.nlm.nih.gov/pubmed/22745653
http://dx.doi.org/10.1371/journal.pone.0035325
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