Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes

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References

  1. 1.

    Coecke, S., Balls, M., Bowe, G., Davis, J., Gstraunthaler, G., Hartung, T., et al. (2005). Second ECVAM task force on Good Cell Culture practice. Guidance on good cell culture practice: a report of the second ECVAM task force on good cell culture practice. Alternatives to Laboratory Animals, 33, 261–287.

    CAS  PubMed  Google Scholar 

  2. 2.

    ISBER. (2007). Best practices for repositories I: collection, storage, and retrieval of human biological materials for research. Cell Preservation Technology, 3, 5–48.

    Google Scholar 

  3. 3.

    OECD (2007) Best Practice Guidelines for Biological Resource Centres; OECD, Paris. http://www.oecd.org/document/50/0,3343,en_2649_201185_1911986_1_1_ 1_1,00.html

  4. 4.

    OECD Advisory Document of the Working Group on Good Laboratory practice: the application of the principles of GLP to in vitro studies. OECD series on principles of Good laboratory practice and Compliance monitoring 2004; Number 14 (ENV/JM/MONO(2004)26), OECD, Paris. http://www.olis.oecd.org/olis/2004doc.nsf/linkTo/nT00008FEE/$FIlE/JT00174939.PdF

  5. 5.

    International Conference on Harmonisation. ICH Topic Q 5 D Quality of Biotechnological Products: derivation and characterisation of cell substrates used for production of Biotechnological/Biological Products (CPMP/ICH/294/95), 1998; ICH Technical Coordination, European Medicines Evaluation Agency, London.

  6. 6.

    WHO (Expert Committee on Biological Standardization and Executive Board) requirements for the use of animal Cells as in vitro substrates for the production of biologicals (requirements for Biological substances no. 50). 1998; WHO technical report series no. 878; World Health Organization, Geneva.

  7. 7.

    Chatterjee, R. (2007). Cell biology: cases of mistaken identity. Science, 315, 928–931.

    Article  CAS  PubMed  Google Scholar 

  8. 8.

    NIH (2007) Notice regarding authentication of cultured cell lines, NOTod-08-017, Nov 28, NiH. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-017.html

  9. 9.

    Editorial (2007). Nature Biotechnology, 1211–1212.

  10. 10.

    International Stem Cell Initiative: Adewumi, O., Aflatoonian, B., Ahrlundrichter, L, Amit, M., Andrews, P. W., Beighton, G., et al. (2007). Characterization of human embryonic stem cell lines by the International Stem Cell Initiative. Nature Biotechnology, 25, 803–816.

    Google Scholar 

  11. 11.

    Sikkema-Raddatz, B., Castedo, B., & Meerman, G. T. (1997). Probability tables for exclusion of mosaicism in prenatal diagnosis. Prenatal Diagnosis, 17, 115–118.

    Article  CAS  PubMed  Google Scholar 

  12. 12.

    Hook, E. B. (1977). Exclusion of chromosomal mosaicism: tables of 90%, 95% and 99% confidence limits and comments on use. American Journal of Human Genetics, 29, 94–97.

    CAS  PubMed  Google Scholar 

  13. 13.

    Association of Clinical Cytogenetics General Best Practice Guidelines. 2007; v10.01, ACC Professional Standards Committee.

  14. 14.

    An International System for Human Cytogenetic Nomenclature (2009) In L. G. Shaffer, M. L. Slovak, L. J. Campbell (Eds.), Cytogenetic and Genome Research. Switzerland: Karger.

  15. 15.

    Bolske, G. (1988). Survey of mycoplasma infections in cell cultures and a comparison of detection methods. Zbl Bakt Nug, A269, 331–340.

    Google Scholar 

  16. 16.

    Rottem, S., & Naot, Y. (1998). Subversion and exploitation of host cells by mycoplasma. Trends in Microbiology, 6, 436–440.

    Article  CAS  PubMed  Google Scholar 

  17. 17.

    Timenetsky, J., Santos, L. M., Buzinhani, M., & Mettifogo, E. (2006). Detection of multiple mycoplasma infection in cell cultures by PCR. Brazilian Journal of Medical and Biological Research, 39, 907–914.

    Article  CAS  PubMed  Google Scholar 

  18. 18.

    Eldering, J. A., Felton, C., Veilleux, C. A., & Potts, B. J. (2004). Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins. Biologicals, 32, 183–193.

    CAS  PubMed  Google Scholar 

  19. 19.

    van Kuppeveld, F. J. M., Johansson, K.-E., Galama, J. M. D., Kissing, J., Bolske, G., van der Logt, J. T. M., et al. (1994). Detection of mycoplasma contamination in cell cultures by a mycoplasma group-specific PCR. Applied and Environmental Microbiology, 60, 149–152.

    PubMed  Google Scholar 

  20. 20.

    Sung, H., Kang, S. H., Bae, Y. J., Hong, J. T., Chung, Y. B., Lee, C.-K., et al. (2006). PCR-Based Detection of mycoplasma species. Journal of Microbiology, 44, 42–49.

    CAS  Google Scholar 

  21. 21.

    Uphoff, C. C., & Drexler, H. G. (2005). Detection of mycoplasma contaminations. Methods in Molecular Biology, 290, 13–23.

    CAS  PubMed  Google Scholar 

  22. 22.

    Kong, H., Volokhov, D. V., George, J., Ikonomi, P., Chandler, D., Anderson, C., et al. (2007). Application of cell culture enrichment for improving the sensitivity of mycoplasma detection methods based on nucleic acid amplification technology (NAT). Applied Microbiology and Biotechnology, 77, 223–232.

    Article  CAS  PubMed  Google Scholar 

  23. 23.

    Healy, L. E., Ludwig, T. E., & Choo, A. (2008). International banking: checks, deposits and withdrawals. Cell Stem Cell, 2(4), 305–306.

    Article  CAS  PubMed  Google Scholar 

  24. 24.

    Crook, J. M., Hei, D., & Stacey, G. (2010). International Stem Cell Banking Initiative (ISCBI): Raising standards to bank on. In Vitro Cell Dev Biol-Animal, (in press).

Download references

Acknowledgements

We would like to thank the International Stem Cell Forum for funding this initiative. Details of the ‘Forum’ can be found at www.stemcellforum.org. Thanks also to the Jackson Laboratory (Bar Harbor, Maine, USA) who hosted meetings of the International Stem Cell Banking Initiative to establish this guidance and to Mrs Gill Cathro who assisted in the preparation of these meetings.

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Websites

www.stemcellforum.org

www.cytogenetics.org.uk/prof_standards/acc_general_bp_mar2007_1.01.pdf

www.iata.com

www.wfcc.org

www.wipo.int/members/en

Contributors

The International Stem Cell Banking Initiative contributors

Peter W. Andrews1, Javard Arias-Diaz2, Jonathan Auerbach3, Manuel Alvarez4, Lars Ahrlund-Richter5, Duncan Baker6, Nissim Benvenisty7, Dalit Ben-Josef8, Guillaume Blin9, Lodovica Borghese10, Joeri Borstlap11. Kevin Bruce12, Oliver Brüstle13, Robin Buckle14, Carine Camby16, Andre Choo17, Wannhsin Chen18, Daniel Collins12, Alan Colman19,Catriona Crombie14, Jeremy Crook20, Ray Cypess21, Paul De Sousa12, Jyotsna Dhawan22, Luc Douay23, Petr Dvorak24, Timothy Dyke25, Lena Eriksson26, Meri Firpo27, Claire Fitzgerald28, Clive Glover29, Paul Gokhale2, Michele Greene30, Hye-Yeong Ha31, Ales Hampl24, 32, Lyn Healy 15, Derek Hei34, Frida Holm5, Outi Hovatta5, Charles Hunt15, Shiaw-Min Hwang35, Maneesha Inamdar36, Rosario Isasi37, Joseph Itskovitz-Eldor38, Nancy Jessie39, Dong-Wook Kim40, Rosemarie Kirzner21, Sorapop Kiatpongsan41, Barbara Knowles42, Hung-Chih Kuo43, Mary Laughlin44, Neta Lavon45, Tenneille Ludwig46, Majlinda Lakov47, Dong-Ryul Lee48, John Macauley49, Ronald McKay50, Phillipe Menasche51, Pablo Menendez52, Anna Michalska53, Maria Mileikovskaia54, Stephen Minger55, Gyan Mishra56, Jennifer Moody29, Karen Montgomery57, Clive Morris25, Christine Mummery58, Andras Nagy59, Yukio Nakamura60, Norio Nakatsuji61, Shin-Ichi Nishikawa62, Steve Oh17, Sun Kyung Oh63, Patricia Olson64, Timo Otonkoski65, Milind Patole56, Hyun-Sook Park66, Xuetao Pei67, Martin Pera68, Michel Puceat9, Kristiina Rajala69, Benjamin Reubinoff70, Allan Robins71, Heather Rooke72, Victor Rumayor2, Heli Scotman69, Jon Sherlock73, Carlos Simon74, Douglas Sipp62, Rebecca Skinner53, David Smith75, Glyn Stacey15, Sonia Stefanovic9, Raimund Strehl76, Robert Taft49, Tsuneo Takahashi77, Sohel Talib64, Stefanie Terstegge13, Rodney Turner73, Timo Tuuri65, John Yu81, Peter Zandstra4, Augustin Zapata2, Fanyi Zeng78, Qi Zhou79, Shelly Tannenbaum80.

Project coordinator and corresponding author: Glyn N Stacey, National Institute for Biological Standards and Control (NIBSC), South Mimms, Hertfordshire, UK (Glyn.Stacey@nibsc.hpa.org.uk).

Contributors Affiliations

1Centre for Stem Cell Biology, University of Sheffield, UK. 2Instituto de Salud Carlos III, Madrid, Spain. 3GlobalStem, Inc.Rockville, U.S.A. 4University of Toronto, Canada. 5Karolinska Institute, Stockholm, Sweden. 6National Health Service/University of Sheffield, UK. 7Hebrew University of Jerusalem, Institute of Life Sciences, Jerusalem, Israel. 8Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, 9INSERM, Evry, France. 10University of Bonn, Bonn, Germany. 11Charité-University Medicine Berlin, Berlin, Germany. 12Roslin Cells, Edinburgh, Scotland UK. 13Institute of Reconstructive Neurobiology, University of Bonn, Germany. 14Medical Research Council, London, UK. 15National Institute for Biological Standards and Control, South Mimms, UK. 16formerly Agence de la Biomedicine, Paris, France, 17Bioprocessing Technology Institute, Singapore. 18Industrial Technology Research Institute, Hsinchu, Taiwan. 19A-Star (formerly ESI), Biopolis, Singapore. 20O’Brien Institute, Melbourne, Australia (formerly of, A-Star, Singapore). 21American Type Culture Collection, Mannassas, Virginia, USA. 22Centre for Cellular and Molecular Biology, Hyderabad, India. 23Universitė Pierre et Marie Curie, Paris, France. 24Masaryk University, Brno, Czech Republic. 25National Health and Medical Research Council, Canberra, Australia. 26formerly University of York, York, UK, 27Stem Cell Institute and Schulze Diabetes Institute, University of Minnesota, Minneapolis, Minnesota, USA. 28Harvard University, Howard Hughes Medical Institute, Boston, USA. 29Stem Cell technologies, Canada. 30formerly Millipore. 31Korean Stem Cell Research Center & Yonsei University College of Medicine, Seoul, Korea. 32Institute of Experimental Medicine, Brno, Czech Republic. 33Waisman Center, University of Wisconsin-Madison, Wisconsin, USA. 35Bioresource Collection and Research Center, Taipei, Taiwan. 36Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India. 37Universite de Montreal, Montreal, Canada (ISCF Ethics Working Party representative). 38Rambam Medical Centre and Technion Institute of technology, Haifa, Isreael, 39R&D Systems. 40Stem Cell Research Center Yonsei University College of Medicine, Seoul, Korea. 41Chulalongkorn University, Bangkok, Thailand, 42Institute of Medical Biology, A*Star, Singapore 43Genomics Research Center/Institute of Cellular and Organismic Biology, Academia Sinica, Taipei, Taiwan. 44Case Medical Center/ISCT, Cleveland University Hospital, Cleveland (International Society for Cell Therapy representative), 45Institute of Life Sciences, The Hebrew University of Jerusalem, Israel. The International Stem Cell Institute, Cedars-Sinai Medical Center, Los Angeles, USA. 46Wicell Research Institute, Wisconsin. 47Newcastle Centre for Life, Newcastle, UK. 48Cha Hospital, Seoul, South Korea. 49The Jackson Laboratory, Bar Harbor, USA. 50National institutes of Health, Washington, USA. 51Hospital European, Georges Pompidou, Paris, France 52Andalusian Stem Cell Bank, Granada, Spain.53Australian Stem Cell Centre, Melbourne, Australia. 54Mount Sinai Hospital, Ontario, Canada.55Kings College London, UK. 56National Centre for Cell Science, Pune, India. 57WiCell Research Institute, Madison, USA. 58Leiden University Medical Center, Leiden, The Netherlands. 59Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Toronto, Canada. 60Riken BioResource Center, Ibaraki, Japan. 61Kyoto University, Kyoto, Japan. 62Riken Center for Developmental Biology, Kobe, Japan. 63IRMP, MRC, Seoul National University College of Medicine, Seoul, South Korea, 64California Institute for Regenerative Medicine, San Francisco, USA. 65University of Helsinki, Helsinki, Finland. 66MCTT Inc., Seoul, South Korea. 67Beijing Institute for Transfusion, Beijing, China. 68University of Southern California, Los Angeles, USA. 69Regea - Institute for Regenerative Medicine, University of Tampere, Tampere University Hospital, Tampere, Finland. 70Hadassah University Medical Organization, Jerusalem, Israel. 71Novocell Inc., Athens, USA. 72International Society for Stem Cell Research, Deerfield, USA. 73Applied Biosystems part of Life Technologies, Foster, USA. 74University of Valencia, Valencia, Spain. 75CABI Europe-UK, Egham, UK. 76Cellartis AB, Goteborg, Sweden. 77University of Tokyo, Tokyo, Japan. 78Shanghai JiaoTong University, Shanghai Institute of Medical Genetics, Shanghai, China. 79Chinese Academy of Sciences, Beijing, China. 80Hebrew University Medical Center, Jerusalem, Israel. 81Genomics Research Center/Institute of Cellular and Organismic Biology, Academia Sinica, Tapei, Taiwan.

The complete list of contributors to the International Stem Cell Banking Initiative are listed at the end of the paper. Correspondance should be directed to G Stacey at Glyn.Stacey@nibsc.hpa.org.uk

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The International Stem Cell Banking Initiative. Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes. Stem Cell Rev and Rep 5, 301–314 (2009). https://doi.org/10.1007/s12015-009-9085-x

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Keywords

  • Human embryonic stem cells
  • Cell banking
  • Standardisation
  • Microbiological testing
  • Pluripotency
  • Quality control