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Points to Consider in the Development of Seed Stocks of Pluripotent Stem Cells for Clinical Applications: International Stem Cell Banking Initiative (ISCBI)

Andrews, PW, Baker, D, Benvinisty, N, Miranda, B, Bruce, K, Br…#x00FC;stle, O, Choi, M, Choi, Y-M, Crook, JM, de Sousa, PA, Dvorak, P, Freund, C, Firpo, M, Furue, MK, Gokhale, P, Ha, H-Y, Han, E, Haupt, S, Healy, L, Hei, DJ, Hovatta, O, Hunt, C, Hwang, S-M, Inamdar, MS, Isasi, RM, Jaconi, M, Jekerle, V, Kamthorn, P, Kibbey, MC, Knezevic, I, Knowles, BB, Koo, S-K, Laabi, Y, Leopoldo, L, Liu, P, Lomax, GP, Loring, JF, Ludwig, TE, Montgomery, K, Mummery, C, Nagy, A, Nakamura, Y, Nakatsuji, N, Oh, S, Oh, S-K, Otonkoski, T, Pera, M, Peschanski, M, Pranke, P, Rajala, KM, Rao, M, Ruttachuk, R, Reubinoff, B, Ricco, L, Rooke, H, Sipp, D, Stacey, GN, Suemori, H, Takahashi, TA, Takada, K, Talib, S, Tannenbaum, S, Yuan, B-Z, Zeng, F, Zhou, Q·2015·Regenerative Medicine
DOI 10.2217/rme.14.93
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Abstract

In 2009 the International Stem Cell Banking Initiative (ISCBI) contributors and the Ethics Working Party of the International Stem Cell Forum published a consensus on principles of best practice for the procurement, cell banking, testing and distribution of human embryonic stem cell (hESC) lines for research purposes [1], which was broadly also applicable to human induced pluripotent stem cell (hiPSC) lines. Here, we revisit this guidance to consider what the requirements would be for delivery of the early seed stocks of stem cell lines intended for clinical applications.

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Metadata

Authors
Andrews, P., Baker, D., Benvinisty, N., Miranda, B., Bruce, K., Br…#x00FC;stle, O., Choi, M., Choi, Y.-M., Crook, J., de Sousa, P., Dvorak, P., Freund, C., Firpo, M., Furue, M., Gokhale, P., Ha, H.-Y., Han, E., Haupt, S., Healy, L., Hei, D., Hovatta, O., Hunt, C., Hwang, S.-M., Inamdar, M., Isasi, R., Jaconi, M., Jekerle, V, Kamthorn, P., Kibbey, M., Knezevic, I., Knowles, B., Koo, S.-K., Laabi, Y., Leopoldo, L., Liu, P., Lomax, G., Loring, J., Ludwig, T., Montgomery, K., Mummery, C., Nagy, A., Nakamura, Y., Nakatsuji, N., Oh, S., Oh, S.-K., Otonkoski, T., Pera, M., Peschanski, M., Pranke, P., Rajala, K., Rao, M., Ruttachuk, R., Reubinoff, B., Ricco, L., Rooke, H., Sipp, D., Stacey, G., Suemori, H., Takahashi, T., Takada, K., Talib, S., Tannenbaum, S., Yuan, B.-Z., Zeng, F., & Zhou, Q.
Affiliations
  • Department of Biomedical Science, The University of Sheffield, Sheffield,UK
  • Sheffield Diagnostic Genetic Services (National Health Se rvice) / Centre for Stem Cell Biology (University of Sheffield), UK
  • Stem Cell Unit, Department of Genetics, Silberman Institute of Life Sciences, The Hebrew University, Jerusalem, Israel
  • Biobank Andalousian Public Health System, Spain
  • Roslin Cells Ltd, Scottish Centre for Regenerative Medicine, UK
  • Institute of Reconstructive Neurobiology, University of Bonn; German Centre for Neurodegenerative Diseases, Bonn, Germany
  • Ministry of Food and Drugs Safety (MFDS) (KFDA), Oosong, Republic of Korea
  • Institute of Reproductive Medicine …amp; Population, Medical Research Center, Seoul National University, Seoul, Republic of Korea
  • Synthetic Biosystems Laboratory, ARC Centre of Excellence for Electromaterials Science, Intelligent Polymer Research Institute, AIIM Facility, Innovation Campus, University of Wollongong, Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Department of Surgery – St Vincent‘s Hospital, The University of Melbourne, Fitzroy, Australia
  • Centre for Clinical Brain Sciences, University of Edinburgh; Roslin Cells Ltd, Edinburgh, UK
  • Department of Biology, Faculty of Medicine, Masaryk University, Czech Republic
  • Department of Anatomy and Embryology, Leiden University Medical Centre, The Netherlands
  • Stem Cell Institute, Department of Medicine, Division of Endocrinology, University of Minnesota, USA
  • National Institute of Biomedical Innovation, Japan
  • Korea National Institute for Health (KNIH)l, Republic of Korea
  • LIFE … BRAIN GmbH, Bonn, Germany
  • UK Stem Cell Bank, Division of Advanced Therapies, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, EN6 3QG, UK: Division of Cell Biology … Imaging, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK.
  • Waisman Center, University of Wisconsin, Madison, USA
  • Karolinska Institutet, Sweden
  • Bioresource Collection and Research Center, inchu, Taiwan
  • Molecular Biology and Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India
  • Centre of Genomics and Policy, McGill University and Génome Québec Innovation Centre, Canada
  • Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospitals of Geneva (HUG), Faculty of Medicine, Geneva University, Switzerland
  • European Medicines Agency, London, UK
  • Faculty of Veterinary Science, Chulalogcorn University, Thailand
  • United States Pharmacopeia, Bethesda, USA
  • World Health Organisation, Geneva, Switzerland
  • The Jackson Laboratory, Bar Harbor, Maine, USA and the Siriraj Center of Excellence for Stem Cell Research, Mahidol University, Bangkok, Thailand
  • I-Stem AFM Inserm Évry., France
  • Andalousian Initiative Advanced Therapies (IATA), Spain
  • Wellcome Trust Sanger Institute, Cambridge, UK
  • California Institute for Regenerative Medicine, San Francisco, USA
  • Center for Regenerative Medicine, The Scripps Research Institute, La Jolla, California, USA
  • WiCell Research Institute, Wisconsin, USA
  • Centre for Stem Cells and Tissue Engineering, Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Canada
  • Cell Engineering Division, RIKEN BioResource Center, Tsukuba, Japan
  • Institute for Integrated Cell-Material Sciences (WPI-iCeMS), Kyoto University, Japan
  • Stem Cell Group, Bioprocessing Technology Institute, A*STAR, Singapore
  • Research Programs Unit, Molecular Neurology and Biomedicum Stem Cell Centre, University of Helsinki Helsinki, Finland
  • Florey Neuroscience and Mental Health Institute, and Walter and Eliza Hall Institute of Medical Research, University of Melbourne, Australia
  • Hematology and Stem Cell Laboratory, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Brazil
  • Heart group, BioMediTech, University of Tampere, Tampere, Finland
  • Regenerative Medicine, New York Stem Cell Foundation, USA
  • Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel
  • International Society for Stem Cell Research, USA
  • RIKEN Center for Developmental Biology, Japan
  • Department of Embryonic Stem Cell Research, The Institute of Frontier Medical Sciences, Kyoto University, Japan
  • National Institutes for Food and Drug Control, Beijing, China
  • Shanghai Institute of Medical Genetics and Shanghai Stem Cell Institute, Shanghai Jiao Tong University School of Medicine, China
  • State key laboratory of Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing, China
Venue
Regenerative Medicine
Publisher
Informa UK Limited
Published
2015-02-12
Volume
10
Issue
sup2
Pages
1-44
ISSN
  • 1746-0751
  • 1746-076X
DOI
10.2217/rme.14.93
Cited by
113
References
8
Language
en
Funders
  • Chinese FZeng, Korean Y Kim; ISCF gran
  • The Ministry of Science and Technology of China (2014CB964700, 2013DFG30680)
  • The Korean National Institute of Health (4861-307210-13)
  • Translational Research of the Ministry of Health, Labor and Welfare of Japan

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