Assessing the Safety of Human Pluripotent Stem Cells and Their Derivatives for Clinical Applications
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Peer-reviewed
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Abstract
Pluripotent stem cells may acquire genetic and epigenetic variants during culture following their derivation. At a conference organized by the International Stem Cell Initiative, and held at The Jackson Laboratory, Bar Harbor, Maine, October 2016, participants discussed how the appearance of such variants can be monitored and minimized and, crucially, how their significance for the safety of therapeutic applications of these cells can be assessed. A strong recommendation from the meeting was that an international advisory group should be set up to review the genetic and epigenetic changes observed in human pluripotent stem cell lines and establish a framework for evaluating the risks that they may pose for clinical use.
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Keywords
Cytogenetic Analysis, Epigenesis, Genetic, Genetic Variation, Humans, Maine, Pluripotent Stem Cells, Regenerative Medicine, Risk Assessment
Journal Title
Stem Cell Reports
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Journal ISSN
2213-6711
2213-6711
2213-6711
Volume Title
9
Publisher
Elsevier
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Sponsorship
Medical Research Council (MR/L012537/1)
Funding for The International Stem Cell Initiative and for this meeting were provided by the International Stem Cell Forum (http://www.stem-cell-forum.net). Additional support for the meeting was provided by the Pluripotent Stem Cell Platform, a Hub funded by the UK Regenerative Medicine Platform, grant ref. MR/L012537/1, and also by Ajinomoto Inc., Stem Cell Technologies Inc. and Thermo Fisher Scientific. B.R. is founder, chief scientific officer, shareholder, and has interests in Cell Cure Neurosciences Ltd.