Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

George Q Daley¹, Insoo Hyun², Jane F Apperley³, Roger A Barker⁴, Nissim Benvenisty⁵, Annelien L Bredenoord⁶, Christopher K Breuer⁷, Timothy Caulfield⁸, Marcelle I Cedars⁹, Joyce Frey-Vasconcells¹⁰, Helen E Heslop¹¹, Ying Jin¹², Richard T Lee¹³, Christopher McCabe¹⁴, Megan Munsie¹⁵, Charles E Murry¹⁶, Steven Piantadosi¹⁷, Mahendra Rao¹⁸, Heather M Rooke¹⁹, Douglas Sipp²⁰, Lorenz Studer²¹, Jeremy Sugarman²², Masayo Takahashi²³, Mark Zimmerman²⁴, Jonathan Kimmelman²⁵

Affiliations

¹ Division of Hematology/Oncology, Boston Children's Hospital and Dana Farber Cancer Institute, Boston, MA 02115, USA. Electronic address: george.daley@childrens.harvard.edu.
² Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA.
³ Centre for Hematology, Imperial College, Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
⁴ John van Geest Centre for Brain Repair, Department of Clinical Neuroscience, Cambridge CB2 0PY, UK.
⁵ Department of Genetics, The Azrieli Center for Stem Cells and Genetic Research, The Hebrew University of Jerusalem, Jerusalem 91904, Israel.
⁶ Department of Medical Humanities, Julius Center, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, the Netherlands.
⁷ Center for Cardiovascular Research, Nationwide Children's Hospital, Columbus, OH 43215, USA.
⁸ Health Law Institute, University of Alberta, Edmonton, AB T6G 2H5, Canada.
⁹ University of California San Francisco School of Medicine, San Francisco, CA 94158, USA.
¹⁰ Frey-Vasconcells Consulting, Sykesville, MD 21784, USA.
¹¹ Center for Cell & Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital and Texas Children's Hospital, Houston, TX 77030, USA.
¹² Institute of Health Science, Shanghai JiaoTong University School of Medicine/Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences, Shanghai, 200025, China.
¹³ Harvard Department of Stem Cell and Regenerative Biology, Harvard University, Cambridge MA 02138, USA.
¹⁴ Department of Emergency Medicine, University of Alberta, Edmonton, AB T6G 2B7, Canada.
¹⁵ Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, Department of Anatomy and Neuroscience, University of Melbourne, Melbourne, Parkville, VIC 3010, Australia.
¹⁶ Departments of Pathology, Bioengineering and Medicine/Cardiology, Institute for Stem Cell and Regenerative Medicine, Center for Cardiovascular Biology, University of Washington, Seattle, WA 98109, USA.
¹⁷ Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
¹⁸ The New York Stem Cell Foundation Research Institute, New York, NY 10023, USA; Q Therapeutics, Salt Lake City, UT 84108, USA.
¹⁹ International Society for Stem Cell Research, Skokie, IL 60077, USA.
²⁰ RIKEN Center for Developmental Biology, Kobe, 650-0047 Japan; Keio University School of Medicine, Tokyo, 160-8582 Japan.
²¹ Center for Stem Cell Biology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
²² Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.
²³ Center for Developmental Biology, RIKEN, Kobe, Hyogo 650-0047, Japan.
²⁴ ViaCyte, San Diego, CA 92121, USA.
²⁵ Biomedical Ethics Unit, McGill University, Montreal, QC H3A 1X1, Canada. Electronic address: jonathan.kimmelman@mcgill.ca.

PMID: 27185282
PMCID: PMC4912385
DOI: 10.1016/j.stemcr.2016.05.001

Practice Guideline

Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

George Q Daley et al. Stem Cell Reports. 2016.

. 2016 Jun 14;6(6):787-797.

doi: 10.1016/j.stemcr.2016.05.001. Epub 2016 May 12.

Authors

Affiliations

¹ Division of Hematology/Oncology, Boston Children's Hospital and Dana Farber Cancer Institute, Boston, MA 02115, USA. Electronic address: george.daley@childrens.harvard.edu.
² Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA.
³ Centre for Hematology, Imperial College, Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
⁴ John van Geest Centre for Brain Repair, Department of Clinical Neuroscience, Cambridge CB2 0PY, UK.
⁵ Department of Genetics, The Azrieli Center for Stem Cells and Genetic Research, The Hebrew University of Jerusalem, Jerusalem 91904, Israel.
⁶ Department of Medical Humanities, Julius Center, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, the Netherlands.
⁷ Center for Cardiovascular Research, Nationwide Children's Hospital, Columbus, OH 43215, USA.
⁸ Health Law Institute, University of Alberta, Edmonton, AB T6G 2H5, Canada.
⁹ University of California San Francisco School of Medicine, San Francisco, CA 94158, USA.
¹⁰ Frey-Vasconcells Consulting, Sykesville, MD 21784, USA.
¹¹ Center for Cell & Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital and Texas Children's Hospital, Houston, TX 77030, USA.
¹² Institute of Health Science, Shanghai JiaoTong University School of Medicine/Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences, Shanghai, 200025, China.
¹³ Harvard Department of Stem Cell and Regenerative Biology, Harvard University, Cambridge MA 02138, USA.
¹⁴ Department of Emergency Medicine, University of Alberta, Edmonton, AB T6G 2B7, Canada.
¹⁵ Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, Department of Anatomy and Neuroscience, University of Melbourne, Melbourne, Parkville, VIC 3010, Australia.
¹⁶ Departments of Pathology, Bioengineering and Medicine/Cardiology, Institute for Stem Cell and Regenerative Medicine, Center for Cardiovascular Biology, University of Washington, Seattle, WA 98109, USA.
¹⁷ Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
¹⁸ The New York Stem Cell Foundation Research Institute, New York, NY 10023, USA; Q Therapeutics, Salt Lake City, UT 84108, USA.
¹⁹ International Society for Stem Cell Research, Skokie, IL 60077, USA.
²⁰ RIKEN Center for Developmental Biology, Kobe, 650-0047 Japan; Keio University School of Medicine, Tokyo, 160-8582 Japan.
²¹ Center for Stem Cell Biology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
²² Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.
²³ Center for Developmental Biology, RIKEN, Kobe, Hyogo 650-0047, Japan.
²⁴ ViaCyte, San Diego, CA 92121, USA.
²⁵ Biomedical Ethics Unit, McGill University, Montreal, QC H3A 1X1, Canada. Electronic address: jonathan.kimmelman@mcgill.ca.

PMID: 27185282
PMCID: PMC4912385
DOI: 10.1016/j.stemcr.2016.05.001

Abstract

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

Keywords: EMRO; clinical translation; clinical trials; communication; embryo research; guidelines; stem cells.

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References

1. American College of Obstetricians and Gynecologists ACOG committee opinion no. 347, November 2006: using preimplantation embryos for research. Obstet. Gynecol. 2006;108:1305–1317. - PubMed
1. Caulfield T., Sipp D., Murry C.E., Daley G.Q., Kimmelman J. Confronting stem cell hype. Science. 2016 - PubMed
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1. ESHRE Taskforce on Ethics and Law The moral status of the pre-implantation embryo. Hum. Reprod. 2001;17:1409–1419. - PubMed
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Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

Affiliations

Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous