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Stem Cells International
Volume 2011 (2011), Article ID 498132, 8 pages
doi:10.4061/2011/498132
Review Article
From Banking to International Governance: Fostering Innovation in Stem Cell Research
Centre of Genomics and Policy, McGill University, Montreal, QC, H3A 1A1, Canada
Received 24 March 2011; Accepted 7 June 2011
Academic Editor: Su-Chun Zhang
Copyright © 2011 Rosario Isasi and Bartha M. Knoppers. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Linked References
- J. Hipp and A. Atala, “Sources of stem cells for regenerative medicine,” Stem Cell Reviews, vol. 4, no. 1, pp. 3–11, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- Geron, “Geron initiates clinical trial of human embryonic stem cell-based therapy,” October 2010.
- Advanced Cell Technology, “Advanced cell technology receives FDA clearance for clinical trials using embryonic stem cells to treat age-related macular degeneration,” January 2011.
- K. Takahashi, K. Tanabe, M. Ohnuki et al., “Induction of pluripotent stem cells from adult human fibroblasts by defined factors,” Cell, vol. 131, no. 5, pp. 861–872, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- G. Vogel, “Cellular reprogramming. New technique RiPS open stem cell field,” Science, vol. 330, no. 6001, p. 162, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- M. Csete, “Translational prospects for human induced pluripotent stem cells,” Regenerative Medicine, vol. 5, no. 4, pp. 509–519, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- R. McKernan, J. McNeish, and D. Smith, “Pharma's developing interest in stem cells,” Cell Stem Cell, vol. 6, no. 6, pp. 517–520, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- R. M. Isasi and B. M. Knoppers, “Governing stem cell banks and registries: emerging issues,” Stem Cell Research, vol. 3, no. 2-3, pp. 96–105, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- Organisation for Economic Co-operation and Development, The Bioeconomy to 2030: Designing A Policy Agenda, 2009.
- A. Park, “Ten ideas changing the world right now: biobanks,” Times, 2009.
- J. G. Day and G. N. Stacey, “Biobanking,” Molecular Biotechnology, vol. 40, no. 2, pp. 202–213, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- N. Nakatsuji, “Banking human pluripotent stem cell lines for clinical application?” Journal of Dental Research, vol. 89, no. 8, pp. 757–758, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- G. N. Stacey, “Consensus guidance for banking and supply of human embryonic stem cell lines for research purposes: the international stem cell banking initiative,” Stem Cell Reviews and Reports, vol. 5, no. 4, pp. 301–314, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. Borstlap, M. X. Luong, H. M. Rooke et al., “International stem cell registries,” In Vitro Cellular and Developmental Biology, vol. 46, no. 3-4, pp. 242–246, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- L. Noel, “Who guiding principles on human cell, tissue and organ transplantation,” Transplantation, vol. 90, no. 3, pp. 229–233, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- The European Commission, “Commission directive 2006/17/EC of 8 February 2006 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,” Official Journal of the European Union, 2006.
- The European Commission, “Commission directive 2006/86/EC of 24 October 2006 implementing directive 2004/23/EC of the European parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells,” Official Journal of the European Union, 2006.
- N. Nakatsuji, “Banking human pluripotent stem cell lines for clinical application?” Journal of Dental Research, vol. 89, no. 8, pp. 757–758, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- K. D. Sermon, C. Simon, P. Braude, S. Viville, J. Borstlap, and A. Veiga, “Creation of a registry for human embryonic stem cells carrying an inherited defect: joint collaboration between ESHRE and hESCreg,” Human Reproduction, vol. 24, no. 7, pp. 1556–1560, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- Reproductive Genetics Institute, Stem Cell Bank, http://www.reproductivegenetics.com/stem_cell_bank.html.
- WiCell Research Institute, WISC Bank, http://www.wicell.org/index.php?option=com_oscommerce&Itemid=272.
- Organization for economic co-operation and development (OECD), “Creation and governance of human genetic research databases,” 2006.
- G. N. Stacey, “Sourcing human embryonic stem cell lines,” in Human Embryonic Stem Cells: The Practical Handbook, S. Sullivan, C. A. Cowan, and K. Eggan, Eds., John Wiley & Sons, New York, NY, USA, 2007.
- B. M. Knoppers and R. Isasi, “Stem cell banking: between traceability and identifiability,” Genome Medicine, vol. 2, no. 10, p. 73, 2010. View at Publisher · View at Google Scholar · View at PubMed
- B. M. Knoppers and M. H. Abdul-Rahman, “Health privacy in genetic research,” Politics and the Life Sciences, vol. 28, no. 2, pp. 99–101, 2009. View at Publisher · View at Google Scholar · View at Scopus
- B. M. Knoppers, R. Isasi, N. Benvenisty, et al., “Publishing SNP genotypes of human embryonic stem cell lines (hESC): a policy statement,” Stem Cell Reviews and Reports, vol. 7, no. 3, pp. 482–484, 2011. View at Publisher · View at Google Scholar · View at PubMed
- R. M. Isasi and B. M. Knoppers, “Beyond the permissibility of embryonic and stem cell research: substantive requirements and procedural safeguards,” Human Reproduction, vol. 21, no. 10, pp. 2474–2481, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- V. Ozdemir and B. M. Knoppers, “One size does not fit all: toward “upstream ethics”?” American Journal of Bioethics, vol. 10, no. 6, pp. 42–44, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- B. Lo and L. Parham, “Ethical issues in stem cell research,” Endocrine Reviews, vol. 30, no. 3, pp. 204–213, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- A. Zarzeczny, C. Scott, I. Hyun et al., “iPS cells: mapping the policy issues,” Cell, vol. 139, no. 6, pp. 1032–1037, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- C. Hewitt, “Uses and abuses of the concept of governance,” International Social Science Journal, vol. 50, no. 155, p. 105, 2002.
- M. Deschênes and C. Sallée, “Accountability in population biobanking: comparative approaches,” Journal of Law, Medicine and Ethics, vol. 33, no. 1, pp. 40–53, 2005. View at Scopus
- A. Cambon-Thomsen, E. Rial-Sebbag, and B. M. Knoppers, “Trends in ethical and legal frameworks for the use of human biobanks,” European Respiratory Journal, vol. 30, no. 2, pp. 373–382, 2007. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- R. M. Isasi, “Policy interoperability in stem cell research: demystifying harmonization,” Stem Cell Reviews and Reports, vol. 5, no. 2, pp. 108–115, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- P. P. O'Rourke, M. Abelman, and K. G. Heffernan, “Centralized banks for human embryonic stem cells: a worthwhile challenge,” Cell Stem Cell, vol. 2, no. 4, pp. 307–312, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- European Group of Ethics in Science and New Technologies to the European Commission, “Recommendations on the ethical review of HESC FP7 research projects,” Opinion, no. 22, 2007.
- J. Sugarman and A. W. Siegel, “Research ethics: when embryonic stem cell lines fail to meet consent standards,” Science, vol. 322, no. 5900, p. 379, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- K. Aalto-Setälä, B. R. Conklin, and B. Lo, “Obtaining consent for future research with induced pluripotent cells: opportunities and challenges.,” PLoS Biology, vol. 7, no. 2, p. e42, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- B. Lo, L. Parham, A. Alvarez-Buylla et al., “Cloning mice and men: prohibiting the use of iPS cells for human reproductive cloning,” Cell Stem Cell, vol. 6, no. 1, pp. 16–20, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- R. M. Isasi, “Policy interoperability in stem cell research: demystifying harmonization,” Stem Cell Reviews and Reports, vol. 5, no. 2, pp. 108–115, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. Menikoff, “The paradoxical problem with multiple-IRB review,” New England Journal of Medicine, vol. 363, no. 17, pp. 1591–1593, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- The Interagency Advisory Panel on Research Ethics, “Tri-council policy statement: ethical conduct for research involving humans,” 2010.
- The Academy of Medical Sciences, “A new pathway for the regulation and governance of health research,” 2011.
- The Hinxton Group, “Statement on policies and practices governing data and material sharing and intellectual property in stem cell science,” 2010.
- J. Borstlap, M. X. Luong, H. M. Rooke et al., “International stem cell registries,” In Vitro Cellular and Developmental Biology, vol. 46, no. 3-4, pp. 242–246, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. M. Crook, D. Hei, and G. Stacey, “The international stem cell banking initiative (ISCBI): raising standards to bank on,” In Vitro Cellular and Developmental Biology, vol. 46, no. 3-4, pp. 169–172, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- B. J. von Tigerstrom, “The challenges of regulating stem cell-based products,” Trends in Biotechnology, vol. 26, no. 12, pp. 653–658, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- T. Caulfield, A. Zarzeczny, J. McCormick et al., “The stem cell research environment: a patchwork of patchworks,” Stem Cell Reviews and Reports, vol. 5, no. 2, pp. 82–88, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- H. Chen, “Stem cell governance in China: from bench to bedside?” New Genetics and Society, vol. 28, no. 3, pp. 267–282, 2009. View at Publisher · View at Google Scholar · View at Scopus
- E. Rowley and P. Martin, “Barriers to commercialisation and utilisation of regenerative medicine in the UK,” Institute for Science and Society, University of Nottingham, Nottingham, UK, 2009.
- A. Trounson, E. Baum, D. Gibbons, and P. Tekamp-Olson, “Developing a case study model for successful translation of stem cell therapies,” Cell Stem Cell, vol. 6, no. 6, pp. 513–516, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. T. Daniels, G. A. Secker, A. J. Shortt, S. J. Tuft, and S. Seetharaman, “Stem cell therapy delivery: treading the regulatory tightrope,” Regenerative Medicine, vol. 1, no. 5, pp. 715–719, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- A. Trounson, R. G. Thakar, G. Lomax, and D. Gibbons, “Clinical trials for stem cell therapies,” BioMed Central, vol. 9, no. 52, 2011. View at Publisher · View at Google Scholar · View at PubMed
- J. F. Fox, “Human iPSC and ESC translation potential debated,” Nature Biotechnology, vol. 29, pp. 375–376, 2011. View at Publisher · View at Google Scholar · View at PubMed
- D. G. Halme and D. A. Kessler, “FDA regulation of stem-cell-based therapies,” New England Journal of Medicine, vol. 355, no. 16, pp. 1730–1735, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. L. Fox, “FDA scrutinizes human stem cell therapies,” Nature Biotechnology, vol. 26, no. 6, pp. 598–599, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- D. W. Fink, “FDA regulation of stem cell-based products,” Science, vol. 324, no. 5935, pp. 1662–1663, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- E. C. Hayden, “Stem cells: the growing pains of pluripotency,” Nature, vol. 473, no. 7347, pp. 272–274, 2011. View at Publisher · View at Google Scholar · View at PubMed
- N. Amariglio, A. Hirshberg, B. W. Scheithauer et al., “Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient,” PLoS Medicine, vol. 6, no. 2, Article ID e1000029, 2009. View at Publisher · View at Google Scholar · View at PubMed
- D. Lau, U. Ogbogu, B. Taylor, T. Stafinski, D. Menon, and T. Caulfield, “Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine,” Cell Stem Cell, vol. 3, no. 6, pp. 591–594, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- S. Kiatpongsan and D. Sipp, “Offshore stem cell treatments,” Nature Reports Stem Cells. In press. View at Publisher · View at Google Scholar
- O. Lindvall and L. Hyun, “Medical innovation versus stem cell tourism,” Science, vol. 324, no. 5935, pp. 1664–1665, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- C. A. Herberts, M. S. G. Kwa, and H. P. H. Hermsen, “Risk factors in the development of stem cell therapy,” Journal of Translational Medicine, vol. 9, no. 29, 2011. View at Publisher · View at Google Scholar · View at PubMed
- K. Martell, A. Trounson, and E. Baum, “Stem cell therapies in clinical trials: workshop on best practices and the need for harmonization,” Cell Stem Cell, vol. 7, no. 4, pp. 451–454, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- L. Brévignon-Dodin and F. Livesey, “Regulation of tissue-engineered products in the European Union: where are we heading?” Regenerative Medicine, vol. 1, no. 5, pp. 709–714, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- L. Brévignon-Dodin and P. Singh, “ATMP in practice: towards a new industry landscape in tissue engineering,” Journal of Commercial Biotechnology, vol. 15, no. 1, pp. 59–65, 2009. View at Publisher · View at Google Scholar · View at Scopus
- N. Stafford, “Germany tightens law on stem cell treatments,” British Medical Journal, vol. 339, p. b2967, 2009. View at Publisher · View at Google Scholar · View at Scopus
- D. McMahon and H. Thorsteinsdottir, “Regulations are needed for stem cell tourism: insights from China,” American Journal of Bioethics, vol. 10, no. 5, pp. 34–36, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- European Union, “Regulation (EC) No 1394 of the European parliament and of the Council on advanced therapy medicinal products and amending directive 2001/83/EC and regulation (EC) No 726/2004,” O.J. L 324/121, 2007.
- C. K. Schneider and P. Celis, “Challenges with advanced therapy medicinal products and how to meet them,” Nature Reviews Drug Discovery, vol. 9, no. 3, pp. 195–201, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- Therapeutic Goods Administration (TGA), “Australia (2009) biologicals framework implementation,” http://www.tga.gov.au/industry/biologicals-framework.htm.
- Canadian Standards Association, Cells, Tissues, and Organs for Transplantation: General Requirements (Draft Standard-Z900.1), 2nd edition, 2010.
- Food and Drug Administration (FDA), “Briefing document: CTGTAG Meeting #45: cellular therapies derived from human embryonic stem cells—considerations for pre-clinical safety testing and patient monitoring,” April 2008.
- A. Trounson, E. Baum, D. Gibbons, and P. Tekamp-Olson, “Developing a case study model for successful translation of stem cell therapies,” Cell Stem Cell, vol. 6, no. 6, pp. 513–516, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. M. Crook, D. Hei, and G. Stacey, “The international stem cell banking initiative (ISCBI): raising standards to bank on,” In Vitro Cellular and Developmental Biology, vol. 46, no. 3-4, pp. 169–172, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- E. Rowley and P. Martin, “Barriers to the commercialization & utilisation of regenerative medicine in the UK,” Institute for Science and Society, University of Nottingham, Nottingham, UK, 2009.
- J. T. Daniels, G. A. Secker, A. J. Shortt, S. J. Tuft, and S. Seetharaman, “Stem cell therapy delivery: treading the regulatory tightrope,” Regenerative Medicine, vol. 1, no. 5, pp. 715–719, 2006. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- International Cancer Genome Consortium, “E.1. informed consent, access and ethical oversight,” in Proceedings of the E-Consortium Policies and Guidelines, 2008.
- K. Martell, A. Trounson, and E. Baum, “Stem cell therapies in clinical trials: workshop on best practices and the need for harmonization,” Cell Stem Cell, vol. 7, no. 4, pp. 451–454, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- N. Cuende and A. Izeta, “Clinical translation of stem cell therapies: a bridgeable gap,” Cell Stem Cell, vol. 6, no. 6, pp. 508–512, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- J. Morris and S. Coles, “Will the FDA kill adult stem cell medicine?” Humanity+ Magazine, 2009.
- D. Cyranoski, “Korean deaths spark inquiry,” Nature, vol. 468, no. 7323, p. 485, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- A. Nagy and S. E. Quaggin, “Stem cell therapy for the kidney: a cautionary tale,” Journal of the American Society of Nephrology, vol. 21, no. 7, pp. 1070–1072, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- B. M. Simon, C. E. Murdoch, and C. T. Scott, “Pluripotent patents make prime time: an analysis of the emerging landscape,” Nature Biotechnology, vol. 28, no. 6, pp. 557–559, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- M. Eisenstein, “Up for grabs,” Nature Biotechnology, vol. 28, no. 6, pp. 544–546, 2010. View at Publisher · View at Google Scholar · View at PubMed
- I. MacLeod, “US biotech firm seeks Canadian stem cell patent,” The Gazette, 2010, Postemedia News.
- E. Dolgin, “Patents draw new lines in the battle to commercialize stem cells,” Nature Medicine, vol. 16, no. 3, p. 246, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- D. Sipp, “Gold standards in the diamond age: the commodification of pluripotency,” Cell Stem Cell, vol. 5, no. 4, pp. 360–363, 2009. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- Mainichi Newspaper Japan, “Kyoto University gains exclusive rights to iPS-related technology, avoid patent spat,” February 2011.
- A. B. Parson, “Stem cell biotech: seeking a piece of the action,” Cell, vol. 132, no. 4, pp. 511–513, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- T. N. McAllister, N. Dusserre, M. Maruszewski, and N. L'Heureux, “Cell-based therapeutics from an economic perspective: primed for a commercial success or a research sinkhole?” Regenerative Medicine, vol. 3, no. 6, pp. 925–937, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- D. Smith, “Commercialization challenges associated with induced pluripotent stem cell-based products,” Regenerative Medicine, vol. 5, no. 4, pp. 593–603, 2010. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- A. Courtney, P. De Sousa, C. George, G. Laurie, and J. Tait, “Balancing open source stem cell science with commercialization,” Nature Biotechnology, vol. 29, no. 2, pp. 115–116, 2011. View at Publisher · View at Google Scholar · View at PubMed
- D. J. H. Mathews, G. D. Graff, K. Saha, and D. E. Winickoff, “Access to stem cells and data: persons, property rights, and scientific progress,” Science, vol. 331, no. 6018, pp. 725–727, 2011. View at Publisher · View at Google Scholar · View at PubMed
- C. C. George, “Open access and the regulation of commercialisation of human stem cell lines in the UKSCB,” SCRIPTed, vol. 7, no. 2, 2010. View at Publisher · View at Google Scholar
- Y. Joly, T. Caulfield, B. M. Knoppers, E. Harmsen, and T. Pastinen, “Points to consider: the commercialization of genomic research in Canada,” Health Care Policy, vol. 6, no. 2, pp. 24–32, 2010.
- A. Plomer and P. Torremans, Embryonic Stem Cell Patents: European Law and Ethics, Oxford University Press, Oxford, UK, 2009.
- European Court of Justice. Case C-34/10, Oliver Brustle vs. Greenpeace eV. Opinion of Advocate General, March 2011.
- B. M. Knoppers and R. Isasi, “Stem cell banking: between traceability and identifiability,” Genome Medicine, vol. 2, no. 10, 2010. View at Publisher · View at Google Scholar · View at PubMed
- M. Baker, “Caution and hope for the stem cell industry,” Nature Reports Stem Cells. In press. View at Publisher · View at Google Scholar
- T. N. McAllister, N. Dusserre, M. Maruszewski, and N. L'Heureux, “Cell-based therapeutics from an economic perspective: primed for a commercial success or a research sinkhole?” Regenerative Medicine, vol. 3, no. 6, pp. 925–937, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
- E. Zika, D. Paci, A. Braun et al., “A European survey on biobanks: trends and issues,” Public Health Genomics, vol. 14, no. 2, pp. 96–103, 2011, http://www.hinxtongroup.org/Consensus_HG10_FINAL.pdf. View at Publisher · View at Google Scholar · View at PubMed
- S. Fortin, S. Pathmasiri, R. Grintuch, and M. Deschênes, ““Access arrangements” for biobanks: a fine line between facilitating and hindering collaboration,” Public Health Genomics, vol. 14, no. 2, pp. 104–114, 2011. View at Publisher · View at Google Scholar · View at PubMed