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Stem Cell Reports. 2017 Jul 11;9(1):1-4. doi: 10.1016/j.stemcr.2017.05.029.

Assessing the Safety of Human Pluripotent Stem Cells and Their Derivatives for Clinical Applications.

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Department of Biomedical Science, Centre for Stem Cell Biology, University of Sheffield, Sheffield S10 2TN, UK. Electronic address:
The Broad Institute, Cambridge, MA 02142, USA.
Department of Genetics, The Azrieli Center for Stem Cells and Genetic Research, Silberman Institute of Life Sciences, The Hebrew University, Jerusalem 91904, Israel.
UCL Institute of Ophthalmology, 11-43 Bath Street, London EC1V 9EL, UK; Neuroscience Research Institute, University of California, Santa Barbara, CA 93117, USA.
Department of Stem Cell and Regenerative Biology, Harvard University, Cambridge, MA 02138, USA; Department of Molecular and Cellular Biology, Harvard University, Cambridge, MA 02138, USA; Stanley Center for Psychiatric Research, Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA; Harvard Stem Cell Institute, Cambridge, MA 02138, USA.
The Jackson Laboratory, Bar Harbor, ME 04609, USA; Siriraj Center of Excellence for Stem Cell Research, Mahidol University, Bangkok 10700, Thailand.
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto M5G 1X5, Canada; Monash University, ARMI, Melbourne, Victoria 3800, Australia.
Stem Cells Australia, Melbourne Brain Centre, The University of Melbourne, Melbourne, Victoria 3010, Australia; Department of Anatomy and Neurosciences, The University of Melbourne, Melbourne, VIC 3010, Australia; Florey Neuroscience & Mental Health Institute, Melbourne, VIC 3052, Australia; Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC 3052, Australia.
Department of Obstetrics and Gynecology, Hadassah Human Embryonic Stem Cells Research Center, The Goldyne-Savad Institute of Gene Therapy, Hadassah-Hebrew University Hospital, Jerusalem 91120, Israel.
Epigenetics Programme, The Babraham Institute, Cambridge CB22 3AT, UK; Wellcome Trust - Medical Research Council Cambridge Stem Cell Institute, University of Cambridge, Cambridge, CB2 1QR, UK.
UK Stem Cell Bank, Advanced Therapies Division, NIBSC-MHRA, London EN6 3QG, UK.


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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