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Harmonizing standards for producing clinical-grade therapies from pluripotent stem cells

Nature Biotechnology volume 32, pages 724–726 (2014)Cite this article

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A Corrigendum to this article was published on 07 November 2014

This article has been updated

To the Editor:

Generating clinical-grade cells from pluripotent stem cells (PSCs) for use in patients is not simply a matter of complying with current good manufacturing practices (cGMPs) and chemistry and manufacturing controls (CMCs). A range of other issues demand careful attention, including accessing tissue in an ethical manner and adhering to the varied rules and regulations of specific local and national jurisdictions. The current patchwork of practices represents a major hindrance to progress in regenerative medicine. We propose the establishment of an international body tasked with developing, evaluating and harmonizing the technical, ethical, legal and regulatory frameworks that govern the production of therapies based on PSCs.

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Figure 1: The manufacturing process for PSC-based therapies.

Change history

  • 10 October 2014

    In the version of this article initially published, two author names were misspelled: the correct names are Cavagnaro, not Cavanagro; Feigal not Feigel. In addition, the name for the Health Insurance Portability and Accountability Act (HIPAA) was given as Health Insurance Portability and Privacy Act (HIPPA). The errors have been corrected in the HTML and PDF versions of the article.

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Author information

Author notes

  1. Mahendra Rao

    Present address: Present address: New York Stem Cell Foundation, New York, New York, USA.,

Authors and Affiliations

  1. Department of Biomedical Science, Centre for Stem Cell Biology, University of Sheffield Western Bank, Sheffield, UK

    Peter W Andrews

  2. Coordinator of the International Stem Cell Initiative,

    Peter W Andrews

  3. Access BIO, Boyce, Virginia, USA

    Joy Cavagnaro

  4. Alliance for Regenerative Medicine/Athersys, Cleveland, Ohio, USA

    Robert Deans

  5. California Institute for Regenerative Medicine, San Francisco, California, USA

    Ellen Feigal

  6. International Society for Cell Therapy, Vancouver, BC, Canada

    Ed Horowitz

  7. American Society of Hematology, University of Toronto and Princess Margaret Cancer Centre, Toronto, ON, Canada

    Armand Keating

  8. National Institutes of Health Center for Regenerative Medicine, Bethesda, Maryland, USA

    Mahendra Rao

  9. Scottish National Blood Transfusion Service Headquarters, Edinburgh, UK

    Marc Turner

  10. Scottish Center for Regenerative Medicine, University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK

    Ian Wilmut

  11. Kyoto Center for iPS Cell Research and Application, Kyoto University, Shogoin, Sakyo-ku, Kyoto, Japan

    Shinya Yamanaka

  12. President of the International Society for Stem Cell Research at the time of submission and acceptance of this work.,

    Shinya Yamanaka

Authors
  1. Peter W Andrews
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  2. Joy Cavagnaro
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  7. Mahendra Rao
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  10. Shinya Yamanaka
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Corresponding author

Correspondence to Mahendra Rao.

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The authors declare no competing financial interests.

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Andrews, P., Cavagnaro, J., Deans, R. et al. Harmonizing standards for producing clinical-grade therapies from pluripotent stem cells. Nat Biotechnol 32, 724–726 (2014). https://doi.org/10.1038/nbt.2973

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