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 Sipp; Lorenz Studer; Jeremy Sugarman; Masayo Takahashi; Mark Zimmerman; Jonathan Kimmelman

doi:10.1016/j.stemcr.2016.05.001

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

Department of Genetics

Research output: Contribution to journal › Comment/debate

151 Scopus citations

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.

Original language	American English
Pages (from-to)	787-797
Number of pages	11
Journal	Stem Cell Reports
Volume	6
Issue number	6
DOIs	https://doi.org/10.1016/j.stemcr.2016.05.001
State	Published - 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).

Keywords

EMRO
clinical translation
clinical trials
communication
embryo research
guidelines
stem cells

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10.1016/j.stemcr.2016.05.001

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Daley, G. Q., Hyun, I., Apperley, J. F., Barker, R. A., Benvenisty, N., Bredenoord, A. L., Breuer, C. K., Caulfield, T., Cedars, M. I., Frey-Vasconcells, J., Heslop, H. E., Jin, Y., Lee, R. T., McCabe, C., Munsie, M., Murry, C. E., Piantadosi, S., Rao, M., Rooke, H. M., ... Kimmelman, J. (2016). Setting global standards for stem cell research and clinical translation: The 2016 ISSCR guidelines. Stem Cell Reports, 6(6), 787-797. https://doi.org/10.1016/j.stemcr.2016.05.001

@article{a7becbe8761b42c8be0be941e0948b1e,

title = "Setting global standards for stem cell research and clinical translation: The 2016 ISSCR guidelines",

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",

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

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: {\textcopyright} 2016 The Author(s).",

year = "2016",

month = jun,

day = "14",

doi = "10.1016/j.stemcr.2016.05.001",

language = "American English",

volume = "6",

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Daley, GQ, Hyun, I, Apperley, JF, Barker, RA, Benvenisty, N, Bredenoord, AL, Breuer, CK, Caulfield, T, Cedars, MI, Frey-Vasconcells, J, Heslop, HE, Jin, Y, Lee, RT, McCabe, C, Munsie, M, Murry, CE, Piantadosi, S, Rao, M, Rooke, HM, Sipp, D, Studer, L, Sugarman, J, Takahashi, M, Zimmerman, M & Kimmelman, J 2016, 'Setting global standards for stem cell research and clinical translation: The 2016 ISSCR guidelines', Stem Cell Reports, vol. 6, no. 6, pp. 787-797. https://doi.org/10.1016/j.stemcr.2016.05.001

TY - JOUR

T1 - Setting global standards for stem cell research and clinical translation

T2 - The 2016 ISSCR guidelines

AU - Daley, George Q.

AU - Hyun, Insoo

AU - Apperley, Jane F.

AU - Barker, Roger A.

AU - Benvenisty, Nissim

AU - Bredenoord, Annelien L.

AU - Breuer, Christopher K.

AU - Caulfield, Timothy

AU - Cedars, Marcelle I.

AU - Frey-Vasconcells, Joyce

AU - Heslop, Helen E.

AU - Jin, Ying

AU - Lee, Richard T.

AU - McCabe, Christopher

AU - Munsie, Megan

AU - Murry, Charles E.

AU - Piantadosi, Steven

AU - Rao, Mahendra

AU - Rooke, Heather M.

AU - Sipp, Douglas

AU - Studer, Lorenz

AU - Sugarman, Jeremy

AU - Takahashi, Masayo

AU - Zimmerman, Mark

AU - Kimmelman, Jonathan

N1 - 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).

PY - 2016/6/14

Y1 - 2016/6/14

N2 - 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.

AB - 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.

KW - EMRO

KW - clinical translation

KW - clinical trials

KW - communication

KW - embryo research

KW - guidelines

KW - stem cells

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U2 - 10.1016/j.stemcr.2016.05.001

DO - 10.1016/j.stemcr.2016.05.001

M3 - Comment/debate

C2 - 27185282

AN - SCOPUS:84966691919

SN - 2213-6711

VL - 6

SP - 787

EP - 797

JO - Stem Cell Reports

JF - Stem Cell Reports

IS - 6

ER -

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

Abstract

Bibliographical note

Keywords

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