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Characterizing International Stem Cell Research Niches

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Regenerative Medicine Ethics

Abstract

Regenerative medicine has evolved differently in global regions, in part due to policies and funding patterns but also due to their styles of governance within particular historical and political conditions. In this chapter, we review global research climates for stem cell-related research, analyzing infrastructure, governance, and funding patterns. We present considerations for reorienting science policy and research program planning gained from our observations and interviews with researchers in sites in North America, Europe, and Asia.

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Notes

  1. 1.

    It is also important to remember that bounded entities such as “the state” may be friction with supranational entities such as the European Union, the World Trade Organization, and other transnational entities attempting to enforce global harmonization of policies, definitions, and practices (Jasanoff 2004).

  2. 2.

    de Vries et al. (2008) track the proportion of articles devoted to HESC, cloning, and other topics, showing the dominance of embryo-oriented concerns of bioethics articles.

  3. 3.

    Chapters 4 and 5 address the tensions between enforced data sharing (especially for genomic data) and capturing intellectual property. Given the debates on synthetic biology in Europe and, to a more limited extent, the USA, and the history of debates and policy implementation on gene therapy, it is remarkable that such issues have not been raised in stem cell research.

  4. 4.

    See, for example, the 2013 report on practices at US-based Precision Stem Cell at http://www.alsworldwide.org/documents/PrecisionStemCellReviewMarch192013.pdf and a subsequent blogpost discussing the report at http://www.healthintheglobalvillage.com/2013/05/06/precision-stemcell-selling-stem-cells-treating-individuals-with-als-as-human-guinea-pigs/.

  5. 5.

    Their work was published in 1963 in Nature (Becker et al. 1963).

  6. 6.

    Coauthor Peter Zandstra is currently Chief Scientific Officer of the CCRM.

  7. 7.

    A summary of the guidelines can be found at http://www.cihr-irsc.gc.ca/e/42071.html.

  8. 8.

    The USA has been extensively discussed elsewhere; therefore, only key points for comparison will be covered here. See, for example, Johnson et al. (2011), Lysaght et al. (2008), Rao (2009), and Salter and Salter (2010).

  9. 9.

    States enacting stem cell funding mechanisms are listed at http://stemcells.nih.gov/research/pages/stateResearch.aspx.

  10. 10.

    CAMR recently merged into the ARM.

  11. 11.

    The statement on August9, 2001 attempted to make a compromise, by allowing limited federal funding for certain lines approved by the NIH as meeting the following criteria: They must have been derived with donor consent and without financial incentives; they must have come from embryos created for reproductive purposes but not used. Lines from 14 countries were initially included; ultimately only 21 were available to researchers for use, as many were of poor quality or had restrictions on use.

  12. 12.

    The National Stem Cell Bank was housed within WiCell at the University of Wisconsin. Federal funding for the bank ended in 2010, but banking services continued as the WISCBank, which now distributes both embryonic and induced pluripotent stem cell lines.

  13. 13.

    Also rescinded was Executive Order 13435 which opened funding for nonembryonic, alternative sources of stem cells. http://www.gpo.gov/fdsys/pkg/FR-2007-06-22/pdf/07-3112.pdf.

  14. 14.

    Sherley v Sibelius U.S. Court of Appeals 11-5241. The case challenged whether embryonic stem cell research would violate the Dickey-Wicker Amendment which prohibits federal funding for any research which harms or destroys embryos. The final ruling favored allowing funding to continue (see Chap. 1).

  15. 15.

    Levine, for example, surveyed 370 US researchers about the effect of the uncertain policy environment regarding embryonic stem cells (2011). The survey was taken after the 2009 US policy change allowing federal funding for HESC research and after Sherley v Sibelius. Of those surveyed, 18 % said that the resulting uncertainty meant they would either delay plans to begin HESC research, and 16 % said it would impede ongoing research (this group included those who had not previously used HESCs but were considering using them). Others reported shifting their research focus from HESCs to induced pluripotent stem cells. The disruption in recruiting new employees, consideration of a relocation, and disruption of collaborations were also mentioned as specific impacts, but these responses constituted fewer than 10 % of respondents. However, only 4 % said they would avoid using HESCs, and 3 % said they would consider relocating.

  16. 16.

    A chart showing the pattern of NIH funding for stem cell research can be found at http://stemcells.nih.gov/research/funding/pages/Funding.aspx. The most recent NIH funding figures, including estimates for 2013, are found at http://report.nih.gov/categorical_spending.aspx. Umbilical cord blood is not counted in these figures, and the categories consist of research using keywords as defined by data mining algorithms, so may not pristeenly reflect actual research projects related to stem cell research.

  17. 17.

    The rationale and goals can be found at http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/00100-r1.en0.htm.

  18. 18.

    The term “knowledge economy” has been applied to the restructuring of economies through specialized expertise. In contrast to mass production or labor which characterized earlier agricultural and industrial manufacturing economies, it is knowledge—particularly in terms of engineering, science, mathematics, and information sciences—that drives the economy, and it is more global and interconnected in scope.

  19. 19.

    There are additional programs, such as the Competitiveness and Innovation Framework Programme (CIP), Education and Training programs, and regional programs for competitiveness. The Innovative Medicines Initiative (IMI), somewhat similar to the National Institutes of Health “critical path initiative” in the USA, is one of the joint programs within FP 7. It was intended to identify new tools and new areas for drug discovery and related health technologies (Goldman 2012). It has a considerable budget; however, in controversial areas such as embryonic stem cell research, there are issues related to coordinating efforts across countries. It has also been criticized because of the large investment required by universities relative to other funding mechanisms (Sinha 2011).

  20. 20.

    Greenpeace v Brüstle (see Chap. 4 and Gibney 2013)

  21. 21.

    Belgium and France further specify that there must be no alternative therapy available (Loi relative à la recherché sur les embryons in vitro (Belgium); Loi no 2011-814 relative à la bioéthique (France)). Unlike most countries which allow embryo research up to 14 days of development, France requires that embryos be destroyed at 7 days. France updated its bioethics laws in 2011 to state that embryo research (including HESC) is only permitted in exceptional cases and is subject to approval by the Biomedicine Agency (see http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205402748_text). Articles 40–44 of the new law reiterate that research should only be done if there is likely to be a major medical breakthrough and there is no better alternative. Danish law derives from law on artificial fertilization, Lov nr 535 omkunstigbefrugtningsomaendretved.

  22. 22.

    A report produced by the Department of Business Innovation & Skills of the Office of Life Sciences, Dept Public Health can be found at http://www.bis.gov.uk/assets/biscore/innovation/docs/t/11-1056-taking-stock-ofregenerative-medicine For a picture of patenting in the UK, see https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/32456/11-1087- regenerative-medicine-patent-landscape.pdf.

  23. 23.

    The catapult has produced a UK cell therapy clinical trial database, which can be found at https://catapult.innovateuk.org/documents/10726/1553967/CTC+UK+Clinical+Trials+Database/0451f336-4e2a-4907-a909-355e940b67b4.

  24. 24.

    See Callon and Rabeharisoa for a detailed study of the way the AFM became a powerful stakeholder in national funding initiatives (2008).

  25. 25.

    Germany is a good illustration of the way that institutional histories shape governance of new areas of science. For a brief but fascinating analysis of the history of ethics decision-making bodies, see Jasanoff (2005, p.196).

  26. 26.

    The Fraunhofer Institute for Immunology and Cell Therapy is also engaged in SC research. Information can be found at http://www.fraunhofer.de/en/research-topics/health-environment-nutrition/regenerative-medicine.html.

  27. 27.

    Regenerationtechnologien für Medizin und Biologie—Beiträge für ein strategisches Förderkonzept (2007) found at http://www.biotechnologie.de/BIO/Redaktion/PDF/de/Studien/capgemini-regmed-2007,property=pdf,bereich=bio,sprache=de,rwb=true.pdf.

  28. 28.

    Hwang Woo-suk was a national celebrity and symbol of Korean resurgence in modern science after the announcement that he had successfully cloned human embryos. Later, it was discovered that he had engaged in scientific fraud and he was removed from his position (cf Gottweis and Kim 2010).

  29. 29.

    The first patient, an American with amyotrophic lateral sclerosis, was offered free treatment in 2005. The procedure was performed at Nanshan Hospital in Shenzhen. Cells from a lab in Zhenzhou were used. Another patient wanted to have cells injected directly into the lamina for multiple sclerosis, but physicians at Nanshen refused; the patient was sent to another province where a clinic was willing to perform the procedure (Song 2011, p 147).

  30. 30.

    People’s Republic of China Ministry of Health (PRC MOH) guidelines for clinical use of biomedical technologies is available at http://www.mmoh.gov.cn/publicfiles/business/htmlfiles/mohyszs/s3585/200903/39511.htm.

  31. 31.

    http://www.mext.go.jp/english/whitepaper/1302732.htm.

  32. 32.

    The derivation of new HESC lines requires a two-stage approval process (Institutional Review Board and Ministry level review). There is also considerable structure regarding research ethics, including a requirement that each institution have bioethics and technical training courses approved by the Ministry.

  33. 33.

    Chapter 2, Sect. 32, concerning “unpatentable inventions” contains the clause: “the inventions liable to contravene public order, morality or public health shall not be patented.” See http://www.wipo.int/clea/docs_new/pdf/en/jp/jp006en.pdf. The language of the law allows some room for interpretation about respecting an embryo while permitting it to be used to create life-saving therapies.

  34. 34.

    The Millennium Project, a national initiative created in 1999 as an economic stimulus project, was intended to develop an infrastructure for science and technology. A public-private collaboration, it was jointly sponsored by the Ministry of Education, Sports, Science and Technology (MEXT); the Science and Technology Agency (STA); the Ministry of Health Labor and Welfare (MHLW); and the Ministry of Economy Trade and Industry (METI), linking education, commerce, and R&D into a networked initiative.

  35. 35.

    Three key genes that code for cell surface proteins involved in the immune response (human leukocyte antigens, or HLA) must be matched to prevent possible rejection of the cells in the recipient. Banked cord blood in Japan will have already been characterized for HLA.

  36. 36.

    These can be found at http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/guidelines.pdf.

  37. 37.

    These are the University of Tokyo, Kyoto University, Osaka University, and Nagoya University.

  38. 38.

    The number of Japanese college students studying overseas dropped by 28 %, from 82,900 in 2004 to 59,900 in 2009, according to figures from the Ministry of Education, Culture, Sports, Science and Technology. In the USA, the number of Japanese scholars has fallen to half of what it was during the peak year of 1997 (Asahi Shimbun; see http://ajw.asahi.com/article/behind_news/people/AJ201210100003).

  39. 39.

    Examples include massive open online courses (MOOCs) such as Coursera, a for-profit company that initially partnered with Stanford University, the University of Michigan, University of Pennsylvania, and Princeton University. Others include Kahn University (a not-for-profit model supported by Google Project 10 and the Gates Foundation) and edX (a not-for-profit partnership of Harvard, MIT, and the École Polytechnique Fédérale de Lausanne in Switzerland). See also Leber (2013). The jury is out on the value and effectiveness of such unconventional offerings. Many universities are rushing to develop similar offerings, hoping to capture revenues during a time of declining public and private support of higher education, but there are numerous hurdles to launching and maintaining courses, including standardization and quality control of course content, licensing, and the time-intensiveness for high-quality, busy professors with little expertise in teaching international audiences to prepare online materials and monitor and evaluate students coming from radically different backgrounds and cultural settings. Language translation is also an issue; currently, most courses are in English only.

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Correspondence to Linda F. Hogle .

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Hogle, L.F., Palecek, S.P., Schaffer, D., Zandstra, P.W. (2014). Characterizing International Stem Cell Research Niches. In: Hogle, L. (eds) Regenerative Medicine Ethics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9062-3_2

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