Abstract
The promise of human pluripotent stem cells to serve as a scalable and renewable starting material for “off the shelf” therapeutic cell products to repair or replace cells and tissues damaged by disease or injury is unparalleled. Whether originating from embryos or the genetic manipulation of adult tissue-derived cells, this prospective impact dictates a comprehensive yet practicable standard of quality assured characterization, blending existing and bespoke standards and considerations. Here, we provide a guide to qualifying the suitability of this resource for human clinical application.
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References
International Stem Cell Banking Initiative (2009) Consensus guidance for banking and supply of human embryonic stem cell lines for research purposes. Stem Cell Rev 5:301–314
Stacey GN, Crook JM, Hei D, Ludwig T (2013) Banking human induced pluripotent stem cells: lessons learned from embryonic stem cells? Cell Stem Cell 13(4):385–388
Crook JM, Peura TT, Kravets L et al (2007) The generation of six clinical-grade human embryonic stem cell lines. Cell Stem Cell 1(5):490–494
De Sousa PA, Downie JM, Tye BJ et al (2016) Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application. Stem Cell Res 17:379–390
Baghbaderani BA, Tian X, Neo BH et al (2015) cGMP-manufactured human induced pluripotent stem cells are available for pre-clinical and clinical applications. Stem Cell Rep 5(4):647–659
Wang J, Hao J, Bai D et al (2015) Generation of clinical-grade human induced pluripotent stem cells in Xeno-free conditions. Stem Cell Res Ther 6:223
Guidance for Industry. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf
HFEA Code of Practice (8th edition), HFEA (2009)
The Human Fertilisation and Embryology Act (2008)
HTA Code of Practice on Research (2009)
Human Tissue (Quality and Safety for Human Application) Regulations 2007
Commission Directive 2006/17/EC: Implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.
Taylor CJ, Peacock S, Chaudhry AN et al (2012) Generating an iPSC bank for HLA-matched tissue transplantation based on known donor and recipient HLA types. Cell Stem Cell 11:147–152
Blood Safety (and Quality) and Regulations, UK Statutory Instrument 2005 No 50 http://www.legislation.gov.uk/uksi/2005/50/pdfs/uksi_20050050_en.pdf
The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) Report: Donations of starting material for advanced therapies. https://www.gov.uk/government/publications/donation-of-starting-material-for-advanced-cell-based-therapies
Krejciova Z, Pells S, Cancellotti E et al (2011) Human embryonic stem cells rapidly take up and then clear exogenous human and animal prions in vitro. J Pathol 223(5):635–645
ISBT 128 managed by ICCBBA: a global standard for the identification, labelling, and information transfer of medical products of human origin. https://www.iccbba.org/tech-library/iccbba-documents/standards-documents.
EU Directive 2015/565 regarding a Single European Code (SEC) for tissues and cells http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L0565&from=EN
Coecke S, Balls M, Bowe G et al (2005) Guidance on good cell culture practice. a report of the second ECVAM task force on good cell culture practice. Altern Lab Anim 33(3):261–287
The International Cell Line Authentication Committee (ICLAC). See http://standards.atcc.org/kwspub/home/the_international_cell_line_authentication_committee-iclac_/
Butler JM, Coble MD, Vallone PM (2007) STRs vs. SNPs: thoughts on the future of forensic DNA testing. Forensic Sci Med Pathol 3(3):200–205
Isasi R, Andrews P, Baltz J et al (2014) Identifiability and privacy in pluripotent stem cell research. Cell Stem Cell 14(4):427–430
Andrews PW, Benvenisty N, McKay R et al (2005) The international stem cell initiative: toward benchmarks for human embryonic stem cell research. Nat Biotechnol 23:795–797
Carpenter MK, Frey-Vasconcells J, Rao M (2009) Developing safe therapies from human pluripotent stem cells. Nat Biotechnol 27:606–613
De Sousa PA, Tye BJ, Bruce K et al (2016) Derivation of the clinical grade human embryonic stem cell line RCe013-A (RC-9). Stem Cell Res 17:36–41
Gropp M, Shilo V, Vainer G et al (2012) Standardization of the teratoma assay for analysis of pluripotency of human ES cells and biosafety of their differentiated progeny. PLoS One 7(9):e45532
Müller FJ, Schuldt BM, Williams R et al (2001) A bioinformatic assay for pluripotency in human cells. Nat Methods 8(4):315–317
Müller F.J., Brändl B., Loring J.F. (2008-2012) Assessment of human pluripotent stem cells with PluriTest. StemBook [Internet]. Cambridge (MA, USA), Harvard Stem Cell Institute
O’Connor MD, Kardel MD, Iosfina I et al (2008) Alkaline phosphatase-positive colony formation is a sensitive, specific, and quantitative indicator of undifferentiated human embryonic stem cells. Stem Cells 26:1109–1116
Zangle T, Chun J, Teitell MA (2013) Quantification of biomass and cell motion in human pluripotent stem cell colonies. Biophys J 105:593–601
Amps K, Andrews PW, Anyfantis G et al (2011) Screening ethnically diverse human embryonic stem cells identifies a chromosome 20 minimal amplicon conferring growth advantage. Nat Biotechnol 29:1132–1144
Association for Clinical Cytogenetics Professional Guidelines for Clinical Cytogenetics, General Best Practice Guidelines, 2007. http://www.acgs.uk.com/media/765607/acc_general_bp_mar2007_1.04.pdf
Peterson SE, Loring JF (2013) Genomic instability in pluripotent stem cells: implications for clinical applications. J Biol Chem 289:4578–4584
Canham MA, Van Deusen A, Brison DR et al (2015) The molecular karyotype of 25 clinical-grade human embryonic stem cell lines. Sci Rep 26(5):17258
Young L, Sung J, Stacey G, Masters JM (2010) Detection of mycoplasma in cell cultures. Nat Protoc 5:929–934
EMA (2010) CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products. Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT), London, 23 June 2011
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Bruce, K.W., Campbell, J.D.M., De Sousa, P. (2017). Quality Assured Characterization of Stem Cells for Safety in Banking for Clinical Application. In: Crook, J., Ludwig, T. (eds) Stem Cell Banking. Methods in Molecular Biology, vol 1590. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-6921-0_6
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DOI: https://doi.org/10.1007/978-1-4939-6921-0_6
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