Setting global standards for stem cell research and clinical translation: The 2016 ISSCR guidelines

George Q. Daley*, Insoo Hyun, Jane F. Apperley, Roger A. Barker, Nissim Benvenisty, Annelien L. Bredenoord, Christopher K. Breuer, Timothy Caulfield, Marcelle I. Cedars, Joyce Frey-Vasconcells, Helen E. Heslop, Ying Jin, Richard T. Lee, Christopher McCabe, Megan Munsie, Charles E. Murry, Steven Piantadosi, Mahendra Rao, Heather M. Rooke, Douglas SippLorenz Studer, Jeremy Sugarman, Masayo Takahashi, Mark Zimmerman, Jonathan Kimmelman

*Corresponding author for this work

Research output: Contribution to journalComment/debate

151 Scopus citations


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.

Original languageAmerican English
Pages (from-to)787-797
Number of pages11
JournalStem Cell Reports
Issue number6
StatePublished - 14 Jun 2016

Bibliographical note

Funding Information:
The authors thank the many individuals and organizations who reviewed the draft guidelines and provided comments or otherwise contributed to our deliberations. Despite earnest efforts to digest and consider all feedback, we apologize for the errors that persist in the document, and invite ongoing comment. As a scientific advisor to the following companies, G.Q.D. receives consulting fees or holds equity in MPM Capital , Epizyme , True North , Solasia , Verastem , Raze , and 28/7. J.F.A. acknowledges the support of the Imperial NIHR-BRC . R.A.B. is an advisor to Living Cell Technologies for a New Zealand-based clinical trial. C.K.B. is the founder of LYST Therapeutics, received grant support from Gunze Limited , and is on the scientific advisory board for Cook Biomedical. H.E.H. is founder of Viracyte and holds a licensing agreement with Cell Medica and a collaborative research agreement with Celgene and Bluebird Bio. M.R. works as a consultant in the field of regenerative medicine and serves on the board and SAB of several companies. The opinions expressed by the author are solely his own and do not reflect the policy or work of the companies he is affiliated with. L.S. is a member of the Scientific Advisory Board of Neurona Therapeutics. J.S. is a member of the Bioethics Advisory Committee and Stem Cell Research Oversight Committee for Merck KGaA, for which he receives consulting income and reimbursement for travel expenses. M.T. has research funds from Healios and Sumitomo Dainippon Pharma . M.Z is an employee of Viacyte, Inc.

Publisher Copyright:
© 2016 The Author(s).


  • EMRO
  • clinical translation
  • clinical trials
  • communication
  • embryo research
  • guidelines
  • stem cells


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