Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes

Andrews, Peter W.; Arias-Dı́az, Javier; Auerbach, Jonathan M.; Alvarez, Manuel; Ährlund‐Richter, Lars; Baker, Duncan; Benvenisty, Nissim; Ben-Josef, Dalit; Blin, Guillaume; Borghese, Lodovica; Borstlap, Joeri; Bruce, Kevin; Brüstle, Oliver; Buckle, Robin; Camby, Carine; Choo, Andre; Chen, Wannshin; Collins, Daniel M.; Colman, Alan; Crombie, Catriona; Crook, Jeremy Micah; Cypess, Ray; Sousa, Paul A. De; Dhawan, Jyotsna; Douay, Luc; Dvořák, Petr; Dyke, T; Eriksson, Lina; Firpo, Meri T.; Fitzgerald, Claire; Glover, Clive H.; Gokhale, Paul J.; Greene, Michele G.; Ha, Hye-Yeong; Hampl, Aleš; Healy, Lyn; Hei, Derek J.; Holm, Frida; Hovatta, Outi; Hunt, Charles J.; Hwang, Shiaw-Min; Inamdar, Maneesha S.; Isasi, Rosario; Itskovitz‐Eldor, Joseph; Jessie, Nancy; Kim, Dong Wook; Kirzner, Rosemarie; Kiatpongsan, Sorapop; Knowles, Barbara B.; Kuo, Hung‐Chih; Laughlin, Mary; Lavon, Neta; Ludwig, Tenneille E.; Lakov, Majlinda; Lee, Dong-Ryul; Macauley, John B.; McKay, Ronald D.G.; Menasche, Phillipe; Menéndez, Pablo; Michalska, Anna; Mileikovskaia, Maria; Minger, Stephen; Mishra, Gyan C.; Moody, Jennifer L.; Montgomery, Karen Dyer; Morris, Clive; Mummery, Christine L.; Nagy, András; Nakamura, Yukio; Nakatsuji, Norio; Nishikawa, Shin‐Ichi; Oh, Steve; Oh, Sun Kyung; Olson, P N; Otonkoski, Timo; Patole, Milind S.; Park, Hyun‐Sook; Pei, Xuetao; Pera, Martin F.; Pucéat, Michel; Rajala, Kristiina; Reubinoff, Benjamin; Robins, Allan J.; Rooke, Heather M.; Rumayor, Victor; Scotman, Heli; Sherlock, Jon; Simón, Carlos; Sipp, Douglas; Skinner, Rebecca R.; Smith, David; Stacey, Glyn; Stefanovic, Sonia; Strehl, Raimund; Taft, Rrobert; Takahashi, Tsuneo; Talib, Sohel; Terstegge, Stefanie; Turner, Rodney; Tuuri, Timo; Yu, John; Zandstra, Peter W.; Zapata, A.; Zeng, Fanyi; Zhou, Qi; Tannenbaum, Shelly E.

doi:10.1007/s12015-009-9085-x

Cited by 135 publications

(41 citation statements)

References 13 publications

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“…Functional assays should follow to evaluate the clinical consequences of antigenic discrepancies. Such characterization efforts are already underway including those coordinated through the International Stem Cell Initiative Consortium, which have determined preliminary census properties of hPSCs by characterizing dozens of hESC lines [36,37], and culture [38] and storage conditions [39]. …”

Section: Maintenance Of Hpsc May Results In Aberrant Antigen Presentationmentioning

confidence: 99%

Immunogenicity of In Vitro Maintained and Matured Populations: Potential Barriers to Engraftment of Human Pluripotent Stem Cell Derivatives

Tang

Drukker

2013

Methods in Molecular Biology

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The potential to develop into any cell type makes human pluripotent stem cells (hPSCs) one of the most promising sources for regenerative treatments. Hurdles to their clinical applications include i) formation of heterogeneously differentiated cultures, ii) the risk of teratoma formation from residual undifferentiated cells, and iii) immune rejection of engrafted cells. The recent production of human isogenic (genetically identical) induced PSCs (hiPSCs) has been proposed as a “solution” to the histocompatibility barrier. In theory, differentiated cells derived from patient-specific hiPSC lines should be histocompatible to their donor/recipient. However, propagation, maintenance, and non-physiologic differentiation of hPSCs in vitro may produce other, likely less powerful, immune responses. In light of recent progress towards the clinical application of hPSCs, this review focuses on two antigen presentation phenomena that may lead to rejection of isogenic hPSC derivates: namely, the expression of aberrant antigens as a result of long-term in vitro maintenance conditions or incomplete somatic cell reprogramming, and the unbalanced presentation of receptors and ligands involved in immune recognition due to accelerated differentiation. Finally, we discuss immunosuppressive approaches that could potentially address these immunological concerns.

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Section: Maintenance Of Hpsc May Results In Aberrant Antigen Presentationmentioning

confidence: 99%

Immunogenicity of In Vitro Maintained and Matured Populations: Potential Barriers to Engraftment of Human Pluripotent Stem Cell Derivatives

Tang

Drukker

2013

Methods in Molecular Biology

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“…We also added two subsections to the Source Cell module, Cell Taxonomy and Anatomical Location. In MIACARM-II, we further added two more sections, Stem Cell Production and Stem Cell Quality Control, to the Source Cell module, according to two publications on stem cell banking [17, 18] and four regulations for products from (stem) cells or tissues in Japan, the U.S., and Europe [19–22]. To describe a single assay, a set of four modules—Assay, Source Cell, Experimental Technology, and Data—are required for reproducibility.…”

Section: Methodsmentioning

confidence: 99%

First Proposal of Minimum Information About a Cellular Assay for Regenerative Medicine

Sakurai

Kurtz

Stacey

et al. 2016

Stem Cells Translational Medicine

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“…In general, from a laboratory safety perspective, it is recommended that end users should request documentation from the supplier on testing for contamination with serious human blood-borne pathogens as identified in the relevant guidance documents (Andrews et al, 2009). …”

Section: Cryopreservationmentioning

confidence: 99%

“…DNA profiling (fingerprinting) should be carried out such as a short tandem repeat method, and the International Stem Cell Banking Initiative (ISCBI, 2009) guidance recommends that key profile loci should be shared between the stem cell bank and researchers in order to enable detection of cross-contamination while not releasing full profiles into the public domain, as these may permit identification of donors (Andrews et al, 2009) by testing cell bank samples using standard methodologies. Publication of full STR data places donors at risk of de-anonymization (ISCBI, 2012;Isasi et al, 2014) and the ANSI standard for STR profiling recommends that limited STR allele information should be shared to permit resolution of instances of cross contamination.…”

Section: Cross-contaminationmentioning

confidence: 99%

Good Cell Culture Practice for stem cells and stem-cell-derived models

Pamies

Bal‐Price

Simeonov

et al. 2016

ALTEX

138

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SummaryThe first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.

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Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes

Cited by 135 publications

References 13 publications

Immunogenicity of In Vitro Maintained and Matured Populations: Potential Barriers to Engraftment of Human Pluripotent Stem Cell Derivatives

Immunogenicity of In Vitro Maintained and Matured Populations: Potential Barriers to Engraftment of Human Pluripotent Stem Cell Derivatives

First Proposal of Minimum Information About a Cellular Assay for Regenerative Medicine

Good Cell Culture Practice for stem cells and stem-cell-derived models

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