Regulation

The ISSCR helps members navigate the regulatory landscape and facilitates the development of stem cell-based interventions and other applications (from tissue transplants to drug screening). The society shares input about scientific findings and considerations to help global regulators make scientifically informed recommendations for the development of stem cell therapies.

Support for Stem Cell Research and Funding

Recent Activity

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Position

ISSCR’s regulatory affairs helps members navigate the international regulatory landscape and facilitates the development of stem cell-based interventions and other applications (from tissue transplants to drug screening). We provide input via meetings and written comments on behalf of our members to the U.S. Food and Drug Administration, the European Medicines Agency, the U.K. Medical and Healthcare products Regulatory Agency, and other regulators about scientific findings and considerations that will help regulators make scientifically informed recommendations for the advancement of stem cell therapies.

ISSCR regulatory affairs is led by the Committee on Manufacturing, Clinical Translation, and Regulation. You may contact this committee here.

Recent Meetings

Steering Committee

  • Shuibing Chen, PhD

    Weill Cornell, USA
    (Co-chair)​

  • Daniela Cornacchia, PhD

    AstraZeneca, Sweden
    (Co-chair)​

  • Luigi Aloia, PhD

    AstraZeneca, UK​

  • Erica Bello, PhD

    Milner Institute, University of Cambridge, UK ​

  • Kapil Bharti, PhD

    NEI/NIH, USA​

  • Hans Clevers, MD, PhD

    Roche, Switzerland ​

  • Magdalena Kasendra, PhD

    Cincinnati Children’s, USA​

  • Henning Kempf, PhD

    GEM CELL hub at Novo Nordisk​

  • Christine Mummery, PhD

    LUMC, Netherlands​

  • Steve Murry, PhD

    Jackson Labs, USA​

  • Hideyuki Okano, MD, PhD

    Keio University, Japan​

  • Li Pang, MD

    FDA, USA​

  • Lee Rubin, PhD

    Harvard University, USA​

  • Charis Segeritz-Walko, PhD

    Novo Nordisk, Denmark ​

  • Clive Svendsen, PhD

    Cedars-Sinai, USA​

  • Carlos Tristan, PhD

    NCATS/NIH, USA​

  • Joseph Wu, MD, PhD

    Stanford University, USA​

  • Matthias Zilbauer, MD, PhD

    University of Cambridge, UK

The ISSCR Standards Initiative is made possible through contributions by:

The ISSCR's Standards for Human Stem Cell Use in Research are strictly copyrighted by the society. No part of this document may be produced in any form without written permission of The International Society for Stem Cell Research. Contact isscr@isscr.org for more information.