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Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing

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Validation of Alternative Methods for Toxicity Testing

Part of the book series: Advances in Experimental Medicine and Biology ((AEMB,volume 856))

Abstract

Quality control of cell cultures used in new in vitro toxicology assays is crucial to the provision of reliable, reproducible and accurate toxicity data on new drugs or constituents of new consumer products. This chapter explores the key scientific and ethical criteria that must be addressed at the earliest stages of developing toxicology assays based on human pluripotent stem cell (hPSC) lines. It also identifies key considerations for such assays to be acceptable for regulatory, laboratory safety and commercial purposes. Also addressed is the development of hPSC-based assays for the tissue and cell types of greatest interest in drug toxicology. The chapter draws on a range of expert opinion within the European Commission/Cosmetics Europe-funded alternative testing cluster SEURAT-1 and consensus from international groups delivering this guidance such as the International Stem Cell Banking Initiative. Accordingly, the chapter summarizes the most up-date best practices in the use and quality control of human Pluripotent Stem Cell lines in the development of in vitro toxicity assays from leading experts in the field.

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Authors and Affiliations

  1. UK Stem Cell Bank, Advanced Therapies Division, NIBSC-MHRA, London, UK

    Glyn N. Stacey

  2. SEURAT-1 Stem Cell Group, Paris, France

    Glyn N. Stacey, Sandra Coecke, Anna-Bal Price, Lyn Healy, Paul Jennings, Anja Wilmes, Christian Pinset, Magnus Ingelman-Sundberg, Jochem Louisse, Simone Haupt, Darren Kidd, Andrea Robitski, Heinz-Georg Jahnke, Gilles Lemaitre & Glenn Myatt

  3. European Commission, Joint Research Centre (JRC), Ispra, Italy

    Sandra Coecke & Anna-Bal Price

  4. Haematopoietic Stem Cell Laboratory, The Francis Crick Institute, 44 Lincoln’s Inn Fields, London, WC2A 3LY, UK

    Lyn Healy

  5. Division of Physiology, Medical University of Innsbruck, Innsbruck, Austria

    Paul Jennings & Anja Wilmes

  6. I-Stem, INSERM/UEVE U861, Evry, France

    Christian Pinset & Gilles Lemaitre

  7. Karolinska Institutet, Solna, Sweden

    Magnus Ingelman-Sundberg

  8. Wageningen University and Research Centre, Wageningen, Netherlands

    Jochem Louisse

  9. Life and Brain, Bonn, Germany

    Simone Haupt

  10. Covance Laboratories Limited, Harrogate, UK

    Darren Kidd

  11. University of Leipzig, Leipzig, Germany

    Andrea Robitski & Heinz-Georg Jahnke

  12. Leadscope, Columbus, OH, USA

    Glenn Myatt

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  1. Glyn N. Stacey
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  8. Magnus Ingelman-Sundberg
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  15. Glenn Myatt
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Correspondence to Glyn N. Stacey .

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  1. SeCAM Services & Consultation on Alternative Methods, Magliaso, Switzerland

    Chantra Eskes

  2. European Commission Joint Research Centre (JRC), Ispra, Italy

    Maurice Whelan

Appendix 1: Ethics Criteria for Cell Lines Selection (hiPSCs and hESCs)

Appendix 1: Ethics Criteria for Cell Lines Selection (hiPSCs and hESCs)

In order to establish that all cell lines were obtained from tissue that has been ethically sourced the researchers must be able to provide evidence for the following:

  • That fully informed consent was obtained and recorded for the donor tissue

  • That consent permits the intended uses of the hPSC lines derived from the donor’s tissue

  • That the donor’s identity was anonymised

  • A validated copy of the original consent form (with donor details redacted) is available and/or a statement is available from a person authorised by the owner or derivation centre on the ethical provenance of the cell line including a contact that would facilitate confirmation of the original consent without breaking donor anonymity.

  • There should be a clear statement on any constraints applied by the donor on the use of derivatives from their cells/tissues.

  • Cell lines are registered within the hESCreg database

  • Copies of blank consent form (or an English translation) and any information provided to the donor are available.

  • Evidence from the donation process that the donor was aware that:

  • Derived lines may be exploited commercially but that donors would not receive personal financial benefit.

  • The donors decision to donate tissue would not influence their personal treatment an there would be no feedback on data from the cell line derived from their tissue. Derived hPSCs could be used for a wide range of purposes in different laboratories and may be tested for genetic characteristics, microbiological contamination and other features of the cells.

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Stacey, G.N. et al. (2016). Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing. In: Eskes, C., Whelan, M. (eds) Validation of Alternative Methods for Toxicity Testing. Advances in Experimental Medicine and Biology, vol 856. Springer, Cham. https://doi.org/10.1007/978-3-319-33826-2_11

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