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References

Published online by Cambridge University Press:  21 May 2025

Margaret Sleeboom-Faulkner
Margaret Sleeboom-Faulkner
Affiliation:
University of Sussex

Information

Type
Chapter
Information
Regulatory Violence
The Global Dynamics of Regulatory Experimentation in Biomedicine and Health
 , pp. 277 - 314
Publisher: Cambridge University Press
Print publication year: 2025
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NC
This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC 4.0 https://creativecommons.org/cclicenses/

References

AABB (2021) Biotherapies: www.aabb.org/news-resources/resources/cellular-therapies [3/1/2024].Google Scholar
Abbot, S., Agbanyo, F., Ahlfors, J.-E., Baghbaderani, B. A., Bartido, S. et al. (2018) Report of the international conference on manufacturing and testing of pluripotent stem cells, Biologicals, 56: 67–83.CrossRefGoogle ScholarPubMed
Abbott, A. (2013) Stem-cell ruling riles researchers, Nature, 495: 418–419.CrossRefGoogle ScholarPubMed
Abbott, K. W., Levi-Faur, D., and Snidal, D. (2017) Introducing regulatory intermediaries, The Annals of the American Academy, 670: 6–13.CrossRefGoogle Scholar
Abertay University (2021) Research reveals UK stem cell clinics using misleading marketing techniques: www.abertay.ac.uk/news/2021/research-reveals-uk-stem-cell-clinics-using-misleading-marketing-techniques/ [3/1/2024].Google Scholar
Abraham, J. (2002) Regulatory science as culture: Contested two-dimensional values at the US FDA, Science as Culture, 11(3): 309–335.CrossRefGoogle ScholarPubMed
Absolute Health (2013) Absolute Health. Regenerative Clinic: https://absolute-health.org/en/?SID=gv5kfkuhj41b6oiqupbb11bgp0 [3/1/2024].Google Scholar
Accesswire (2014) Japan’s bold initiative in regenerative medicine and who the big winners might be. 3 March: http://bit.ly/48gmtzK [3/1/2024].Google Scholar
Adams, R. (2000) Loving mimesis and Girard’s ‘scapegoat of the text’: A creative reassessment of mimetic desire. In Swartley, W. (ed.) Violence Renounced: René Girard, Biblical Studies, and Peacemaking. Telford, PA: Pandora Press US, 277–307: https://web.archive.org/web/20090327074008/http://web.ustpaul.uottawa.ca/covr2006/Document/RebeccaGirard.pdf [3/1/2024].Google Scholar
Alcoff, L. M. (2006) Visible Identities: Race, Gender and the Self. New York: Oxford University Press.CrossRefGoogle Scholar
AMED (2017) AMED: Overseas Offices: www.amed.go.jp/en/aboutus/overseas.html [03/01/2024].Google Scholar
American Academy of Orthopaedic Surgeons (2016) Benefits of stem cells for treating spinal cord injuries assessed: www.sciencedaily.com/releases/2016/04/160429105533.htm.Google Scholar
AMMS (2014) AMMS: www.stemcellscurediabetes.com/The-Academy-of-Military-Medical-Sciences-of-the-PLA-(AMMS).html [05/01/19].Google Scholar
Anderson, M., and McCleary, K. K. (2016) On the path to a science of patient input, Science Translational Medicine, 8(336): 11.CrossRefGoogle ScholarPubMed
Angell, M. (1997) The ethics of clinical research in the Third World, New England Journal of Medicine, 337(12): 847–849.CrossRefGoogle ScholarPubMed
Anonymous, (2010) Wild East or scientific feast, The Economist, 14 January: www.economist.com/science-and-technology/2010/01/14/the-end-of-an-institution [22/1/2024].Google Scholar
Anonymous, (2015) Stem the tide: Japan has introduced an unproven system to make patients pay for clinical trials, Nature, 528(7581): 163–164.Google Scholar
Anonymous, (2021) Scientists raise alarm as Italian government rules on unproven stem cell therapy, EuroStemCell: www.eurostemcell.org/scientists-raise-alarm-italian-government-rules-unproven-stem-cell-therapy [3/1/2024].Google Scholar
Anspach, M. (2017) Vengeance in Revenge. East Lansing: Michigan State University.Google Scholar
Arendt, H. (1970) On Violence. Orlando: Harcourt.Google Scholar
ARM (2016) Homepage: http://alliancerm.org [3/1/2024].Google Scholar
ASCI (2022) Asian Stem Cell Institute: https://asianstemcellinstitute.com/ [3/1/2024].Google Scholar
Athersys (2013) Athersys’ multistem(R) stem cell therapy receives orphan drug designation in Europe for prevention of graft-versus-host disease: https://bit.ly/48DSstt [3/1/2024].Google Scholar
Athersys (2016) Healios and Athersys enter into regenerative medicine partnership for treatment of stroke using MultiStem(R) Therapy (press release). 8 January: www.athersys.com/investors/press-releases/press-release-details/2016/Healios-and-Athersys-Enter-Into-Regenerative-Medicine-Partnership-for-Treatment-of-Stroke-Using-MultiStemR-Therapy/default.aspx [3/1/2024].Google Scholar
Ausbiotech (2021) Ausbiotech: www.ausbiotech.org/about-us/regenerative-medicine-advisory-group [3/1/2024].Google Scholar
Azuma, K. (2015) Regulatory landscape of RM in Japan, Current Stem Cell Report, 1: 118–128.CrossRefGoogle Scholar
Azuma, M., and Yamanaka, S. (2016) Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies, Regenerative Therapy, 4 (2016): 36e47.CrossRefGoogle ScholarPubMed
Baldwin, R., and Black, J. (2007) Really responsive regulation. LSE Law, Society and Economy Working Papers 15/2007. London School of Economics: Law Department.Google Scholar
Batt, S. (2017) Health Advocacy Inc.: How Pharmaceutical Funding Changed the Breast Cancer Movement. Vancouver: University of British Columbia Press.CrossRefGoogle Scholar
B&D (2014) PLA Navy General Hospital: www.stemcellshealthcare.com/about-us/pla-navy-general-hospital [3/1/2024].Google Scholar
Barry, A. (2006) Technological zones, European Journal of Social Theory, 9(2): 239–253.CrossRefGoogle Scholar
Basu, S. (2012) Making a difference: A mother’s courage, The Hindu, 29 February: www.thehindu.com/life-and-style/society/article2945835.ece [3/1/2024].Google Scholar
Begon, M., Harper, J. L., and Townsend, C. R. (2006) Ecology: Individuals, Populations and Communities. From Individuals to Ecosystems. Malden; Oxford; Victoria: Blackwell Science.Google Scholar
BeikeBiotech (2010) Beike Biotech and Premier Wen Jiabao. 12 October: www.youtube.com/watch?v=V8Lgz27EtbE [3/1/2024].Google Scholar
BeikeBiotech (2014) Chinese researchers find stem cells effective in treating Systemic Lupus Erythematosus: https://beikebiotech.com/blog/2014/06/26/chinese-researchers-find-stem-cells-effective-in-treating-systemic-lupus-erythematosus/ [3/1/2024].Google Scholar
BeikeBiotech (2016a) Quality: https://beikebiotech.com/quality/ [3/1/2024].Google Scholar
BeikeBiotech (2016b) Beike History: https://beikebiotech.com/beike-history/ [3/1/2024].Google Scholar
BeikeBiotech (2016c) Partnerships: https://beikebiotech.com/partnerships/ [3/1/2024].Google Scholar
BeikeBiotech (2021a) Stem cell therapy for other conditions: https://stemcelltreatmentnow.com/treatments/general/ [3/1/2024].Google Scholar
BeikeBiotech (2021b) Testimonials: https://stemcelltreatmentnow.com/testimonials/ [3/1/2024].Google Scholar
Bell, C. (2009) Ritual, Ritual Theory, Ritual Practice. Oxford: Oxford University Press.Google Scholar
Bharadwaj, A., and Glasner, P. (2008) Local Cells, Global Science: The Rise of Embryonic Stem Cell Research in India. London; New York: Routledge.CrossRefGoogle Scholar
Bharadwaj, A. (2012) Enculturating cells: The anthropology, substance, and science of stem cells, Annual Review of Anthropology, 41: 303–317.CrossRefGoogle Scholar
Bharadwaj, A (2013) Ethic of consensibility, subaltern ethicality: The clinical application of embryonic stem cells in India, BioSocieties, 8: 25–40.CrossRefGoogle Scholar
Bharadwaj, A. (2013) Subaltern biology? Local biologies, Indian odysseys and the pursuit of human embryonic stem cell therapies, Medical Anthropology, 32(4): 359–373.CrossRefGoogle ScholarPubMed
Bharadwaj, A. (2018) Global Perspectives on Stem Cell Technologies. Basingstoke: Palgrave Macmillan.CrossRefGoogle Scholar
Bianco, P. (2013) Don’t market stem-cell products ahead of proof, Nature, 499: 255.CrossRefGoogle ScholarPubMed
Bianco, P., Cao, X., Frenette, P. S., Mao, J. J., Robey, P. G. et al. (2013a) The meaning, the sense and the significance: translating the science of mesenchymal stem cells into medicine, Nature Medicine, 19: 35–42.CrossRefGoogle ScholarPubMed
Bianco, P., Barker, R., Brüstle, O., Cattaneo, E., Clevers, ., et al. (2013b) Regulation of stem cell therapies under attack in Europe: For whom the bell tolls, EMBO Journal, 32: 1489–1495.CrossRefGoogle ScholarPubMed
Bianco, P. (2014) ‘Mesenchymal’ stem cells, Annual Review of Cell Developmental Biology, 30: 677–704.CrossRefGoogle ScholarPubMed
Bianco, P., and Sipp, D. (2014) Sell help not hope, Nature, 510, 336–337.CrossRefGoogle Scholar
Bioeconomy Corporation (2014) Press Release: www.bioeconomycorporation.my/bionexus-status-companies-poised-for-solid-growth-with-a-record-of-rm4-4-billion-investments-since-inception/ [3/3/2015].Google Scholar
Bionet (2007) Information Paper. The right mix of biology, metaphysics and culture: stem cell research in Europe and China, LSE: www.lse.ac.uk/researchAndExpertise/units/BIONET/pdfs/BIONET_Info_Paper1_Stem_Cell_Research.pdf [3/1/2024].Google Scholar
Bionews Texas (2013) News Release: http://bionews-tx.com/news/2013/03/05/wattanosoth-cancer-hospital-held-the-first-cancer-tumor-board-teleconference-with-the-university-of-texas-md-anderson-cancer-center/Biotechcorp [6/2/2020].Google Scholar
Bipartisan Policy (2016) Bipartisan REGROW Act would advance regenerative cell therapy. Bipartisan Policy Center news release. March 17: https://regmedfoundation.org/2016/03/17/bipartisan-regrow-act-would-advance-regenerative-cell-therapy/ [3/1/2024].Google Scholar
Birch, K. (2012) Knowledge, place, and power: Geographies of value in the bioeconomy, New Genetics and Society, 31(2), 183–201.CrossRefGoogle Scholar
Black, J. (2002) Critical reflections on regulation, Australian Journal of Legal Philosophy 1, 25.Google Scholar
Black, J. (2005) Proceduralisation and polycentric regulation, Revista Direito GV, Especial: www.academia.edu/72462700/Proceduralisation_and_polycentric_regulation [3/1/2024].Google Scholar
Black, J. (2021) Constitutionalising regulatory governance systems (March 27), LSE Legal Studies Working Paper, No. 02/2021: https://ssrn.com/abstract=3813812 or http://dx.doi.org/10.2139/ssrn.3813812 [3/1/2024].CrossRefGoogle Scholar
Blanc, Y., and Bessière, M. (2001) Mark Anspach: Global markets anonymous victims, The Courier, UNESCO: www.markanspach.com/short-reads/anonymous-victims/ [3/1/2024].Google Scholar
Blasimme, A., and Rial-Sebbag, E. (2012) Regulation of cell-based therapies in Europe: Current challenges and emerging issues, Stem Cells Dev., 22(Suppl. 1): 14–19.CrossRefGoogle Scholar
BMJ (2023) Too much medicine: www.bmj.com/too-much-medicine [3/1/2024].Google Scholar
Boland, L. K., Burand, A. J., Boyt, D. T., Dobroski, H., Di, L., Liszewski, J. N., Schrodt, M. V., Frazer, M. K., Santillan, D. A., Ankrum, J. A. (2019) Nature vs. nurture: Defining the effects of mesenchymal stromal cell isolation and culture conditions on resiliency to palmitate challenge, Frontiers in Immunology, 10: https://doi.org/10.3389/fimmu.2019.01080 [3/1/2024].CrossRefGoogle ScholarPubMed
Braithwaite, J. (2008), Regulatory Capitalism: How It Works, Ideas for Making It Work Better. Cheltenham, UK; Northampton, MA: Edward Elgar.CrossRefGoogle Scholar
Brown, C. (2012) Stem cell tourism poses risk, CMAJ, 184(2): E121–E122.CrossRefGoogle Scholar
Brown, N. (2003) Hope against hype: Accountability in biopasts, presents and futures, Science and Technology Studies, 16(2): 3–21.CrossRefGoogle Scholar
Brown, N (2019) Immunitary Life: A Biopolitics of Immunity. Basingstoke: Palgrave Macmillan.CrossRefGoogle Scholar
Brown, N., and Michael, M. (2003) An analysis of changing expectations: Or ‘retrospecting prospects and prospecting retrospects’, Technology Analysis and Strategic Management, 15: 3–18.CrossRefGoogle Scholar
Bufacchi, V. (2005) Two concepts of violence, Political Studies Review, 3(2): 193–204.CrossRefGoogle Scholar
Bufacchi, V. (2007) Violence and Social Justice. Basingstoke: Palgrave MacmillanCrossRefGoogle Scholar
Busch, L. (2000) The Eclipse of Morality. Science, State, and Market. New York: Aldine de GruyterGoogle Scholar
Busch, L. (2011) Standards. Recipes for Reality. Cambridge, MA: MIT Press.CrossRefGoogle Scholar
Calvert, M. J., Marston, E., Samuels, M., Cruz Rivera, S., Torlinska, B., et al. (2021) Advancing UK regulatory science and innovation in healthcare, Journal of the Royal Society of Medicine, 114(1): 5–11.CrossRefGoogle ScholarPubMed
Cambrosio, A., Keating, P., Schlich, T., and Weisz, G. (2006) Regulatory objectivity and the generation and management of evidence in medicine, Social Science & Medicine, 63(1): 189–199.CrossRefGoogle ScholarPubMed
Cancer Hospital Wattanosoth (2024) Bangkok Hospital HQ’s Bangkok Cancer Hospital Wattanosoth and Be Well Medical Center enter into strategic collaboration: www.wattanosothcancerhospital.com/en/news-events/be-well-medical-center-x-bangkok-cancer-hospital-wattanosoth [3/1/2024].Google Scholar
Canguilhem, G. (1989) The Normal and Pathological. Cambridge, MA; London: MIT Press.Google Scholar
Castells, M. (2000) The Rise of the Network Society: The Information Age: Economy, Society, and Culture. New York: John Wiley.Google Scholar
Caulfield, T., and Murdoch, B. (2019) Regulatory and policy tools to address unproven stem cell interventions in Canada: The need for action, BMC Med Ethics, 20: 51.CrossRefGoogle ScholarPubMed
Carpenter, D. (2010) Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton: Princeton University Press.Google Scholar
CBMG (2015) Cellular Biomedical Group, Inc. Securities and Exchange Commission Edgar Filing. 31 March: www.annualreports.com/HostedData/AnnualReportArchive/c/NASDAQ_CBMG_2014.pdf [3/1/2024].Google Scholar
CDSCO (Central Drugs Standard Control Organisation) (2013) Guidance Document for Regulatory Approvals of Stem Cell and Cell Based Products (SCCPs) SCCPs/SPS/2013-001, Version: 004. December 30: www.scribd.com/document/215468898/Guidance-Document-for-Regulatory-Approvals-of-Stem-Cell-and-Cell-Based-Products-SCCPs [3/1/2024].Google Scholar
CDB (2016) How foreign non-profit organisations should respond to China’s new Overseas NGO Management Law: http://chinadevelopmentbrief.cn/articles/how-foreign-non-profit-organisations-should-respond-to-chinas-new-overseas-ngo-management-law/ [3/1/2024].Google Scholar
CDPF (2016) China’s Disabled Persons’ Federation: www.cdpf.org.cn/english/ [5/1/19].Google Scholar
CDPF (2021) 3-sided cooperation between the Civil Affairs Bureau, the China Disabled Persons’ Federation and the Inclusion Factory: https://inclusion-factory.com/en/3761.html [3/1/2024].Google Scholar
CellPort (2022) CellPort International. Stem cell augmentation: www.facebook.com/CellportTH/ [3/1/2024].Google Scholar
Centre for Sustainable Healthcare (2020) Green social prescribing for sustainable healthcare: https://sustainablehealthcare.org.uk/what-we-do/connecting-q-locally/green-social-prescribing-sustainable-healthcare [3/1/2024].Google Scholar
CFDA (2015) 关于印发干细胞临床研究管理办法（试行）的通知 [Guanyu Yinfa ganxibao linchuang yanjiu guanli banfa (shixing) de tongzhi; Administrative Measures for Clinical Research of Stem Cells (for Trial Implementation)], NHFPC. 21 August: www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=28635ef99c5743e294f45e8b29c72309 [3/1/2024].Google Scholar
Chaisinthop, N. (2014) ‘Cell therapy’ in Thailand: Negotiating space, legitimacy, ambiguity and alliances. Paper presented at the Biannual Workshop of the Centre for Bionetworking, University of Sussex. 7 July.Google Scholar
Chan, S., and Harris, J., (2009) Free riders and pious sons: Why scientific research remains obligatory, Bioethics, 23(3): 161–171.CrossRefGoogle ScholarPubMed
Chen, H. (2017) Reflection on the governance of clinical stem cell research and applications in China, Regenerative Medicine, 12(6): 593–597.CrossRefGoogle Scholar
Chen, H., and Gottweis, H. (2013) Stem cell treatments in China: Rethinking the patient role in the global bio-economy, Bioethics, 27(4):194–207.CrossRefGoogle Scholar
Chen, Y.-C., Cheng, H.-F., and Yeh, M.-K. (2017) Cell therapy regulation in Taiwan, Cell Transplantation, 26: 483–492: www.ncbi.nlm.nih.gov/pmc/articles/PMC5657697/ [3/1/2024].CrossRefGoogle ScholarPubMed
China Daily (2016) Alliance for stem cell technologies established in Guangzhou: www.chinadaily.com.cn/china/2016-03/29/content_24169162.htm [3/1/2024].Google Scholar
ChinaSCInet (2020) Clinical trials in ChinaSCINet: www.chinascinet.org/index.php?option=com_content&task=view&id=106&lang=en [2/12/2020].Google Scholar
Chinese Academy of Science (2013) China to further regulate stem cell clinical experiments, 8 March, CAS: https://english.cas.cn/newsroom/archive/china_archive/cn2013/201303/t20130308_99433.shtml [3/1/2024].Google Scholar
Choosing Wisely UK (2023) About Choosing Wisely UK: https://choosingwisely.co.uk/about-choosing-wisely-uk/ [3/1/2024].Google Scholar
Chulalongkorn University (2013) HRH Princess Maha Chakri Sirindhorn presided over grand opening for robotic stem cell processing laboratory at Faculty of Medicine. 8 October: www.chula.ac.th/en/archive/681 [l2/6/2015].Google Scholar
CiRA (2012) 星野利彦教授が着任しました [Hoshino Toshihiko kyōju ga chakunin shimashita (Professor Toshihiko Hoshino has arrived)]. 3 September: www.cira.kyoto-u.ac.jp/j/pressrelease/other/120903-095145.html [3/1/2024].Google Scholar
CIRM (2016) Proposed strategic plan: 2016 & beyond. California Institute for Regenerative Medicine. 8 December: www.cirm.ca.gov/sites/default/files/files/agenda/151217_Agenda_7_CIRM_StratPlan_final_120815.pdf [3/1/2024].Google Scholar
Clinicaltrials.gov (2013) Search ‘Beike Biotech’ http://clinicaltrials.gov/ct2/results?term=beike&Search=Search [3/1/2024].Google Scholar
ClinicalTrials.gov (2016) http://clinicaltrials.gov/ct2/show/NCT01440309 [3/1/2024].Google Scholar
CMI (2023) Global regenerative medicine market 2023–2032: www.custommarketinsights.com/report/regenerative-medicine-market/ [3/1/2024].Google Scholar
Coghlan, A. (2010) Death revives warnings about rogue stem cell clinics. New Scientist, Health. 17 June: www.newscientist.com/article/dn19056-death-revives-warnings-about-rogue-stem-cell-clinics/?ignored=irrelevant [3/1/2024].Google Scholar
Cohen, E. (2009) A Body Worth Defending. Immunity, Biopolitics, and the Apothesosis of the Modern Body. Durham; London: Duke University Press.Google Scholar
Colman, A. (2008) Stem cell research in Singapore, Cell, 132: 519–521.CrossRefGoogle ScholarPubMed
Collins, R. (1968) Competition and social control in science: An essay in theory construction, Sociology of Education, 41 (Spring): 123–140.CrossRefGoogle Scholar
Cookson, R., Doran, T., Asaria, M., Gupta, I., and Parra Mujica, F. (2021) The inverse care law re-examined: A global perspective, The Lancet, 397: 828–838CrossRefGoogle ScholarPubMed
Cooper, J., Blake, I., and Lindsay, J. O., et al. (2017) Living with Crohn’s disease: An exploratory cross-sectional qualitative study into decision-making and expectations in relation to autologous haematopoietic stem cell treatment, BMJ Open, 7: e015201.CrossRefGoogle ScholarPubMed
Cossu, G., Birchall, M., Brown, T., De Coppi, P., Culme-Seymour, E., et al. (2018) Lancet Commission: Stem cells and regenerative medicine, Lancet, 391: 883–910.CrossRefGoogle ScholarPubMed
Cossu, G., Fears, R., Griffin, G., and Ter Meulen, V. (2020) European Academies of Science and Medicine on Regenerative Medicine, Communication Works: https://news.cision.com/communication-works/r/european-academies-of-science-and-medicine-on-regenerative-medicine,c3127112 [3/1/2024].Google Scholar
Croley, S. P. (2007) Regulation and Public Interests. Princeton: Princeton University Press.Google Scholar
CSN (2018) Cell Surgical Network: https://stemcellrevolution.com/#:~:text=Welcome%20to%20the%20Cell%20Surgical%20Network%C2%AE.,of%20inflammatory%20and%20degenerative%20conditions [3/1/2024].Google Scholar
CURE (2009) Medical Research Council: CURE committee report: www.ukri.org/wp-content/uploads/2021/08/MRC-0208212-CURE-committee-report.pdf [3/1/2024].Google Scholar
Curwen, L. (2020) The risks behind the hype of stem-cell treatments, BBC News. 7 January: www.bbc.co.uk/news/health-51006333 [3/1/2024].Google Scholar
Cynata Therapeutics (2016) Proactive: Cynata Therapeutics and Japan’s Regience K.K. in stem cell alliance: www.proactiveinvestors.co.uk/companies/news/135034/cynata-therapeutics-and-japans-regience-kk-in-stem-cell-alliance-67327.html [3/1/2024].Google Scholar
Cyranoski, D. (2010) FDA challenges stem-cell clinic, Nature, 466: 909CrossRefGoogle ScholarPubMed
Cyranoski, D. (2011) Texas prepared to fight for stem cells, Nature, 477, 377–378.Google ScholarPubMed
Cyranoski, D. (2012a) China’s stem cell rules go unheeded, Nature, 484: 149–150.CrossRefGoogle ScholarPubMed
Cyranoski, D. (2012b) FDA’s Claims over stem cells upheld, Nature, 488: 14.CrossRefGoogle ScholarPubMed
Cyranoski, D. (2013a) Controversial stem-cell company moves treatment out of the United States, Nature, 30 January.CrossRefGoogle Scholar
Cyranoski, D. (2013b) Japan to offer fast-track approval path for stem cell therapies, Nature Medicine, 19(5), 510–511.CrossRefGoogle ScholarPubMed
Cyranoski, D. (2014) Still no stem cells via easy ‘STAP’ path, Nature: https://doi.org/10.1038/nature.2014.16606 [3/1/2024].CrossRefGoogle Scholar
Cytori (2015) Japanese approval trial for stress urinary incontinence using Cytori Therapeutics, Inc. cell therapy announced: www.biospace.com/article/releases/japanese-approval-trial-for-stress-urinary-incontinence-using-cytori-therapeutics-inc-cell-therapy-announced-/ [3/1/2024].Google Scholar
Cyranoski, D. (2019) Stem cells 2 go, Nature, 573: 482–485.CrossRefGoogle Scholar
Cyranoski, D., Sipp, D., Malik, S., and Rasko, J. (2023) Too little too soon: Japan’s experiment in regenerative medicine regulation., Cell Stem Cell, 30(7): 913–916.CrossRefGoogle Scholar
Daley, G. Q., Hyun, I., Apperley, J. F., Barker, R. A., and Benvenisty, N., et al. (2016) Setting global standards for stem cell research and clinical translation: The 2016 ISSCR Guidelines, Stem Cell Report, 6: 787–797.CrossRefGoogle ScholarPubMed
Deane-Drummond, C. (2004) The Ethics of Nature. Malden; Oxford; Victoria: Blackwell.CrossRefGoogle Scholar
Deinsberger, J., Reisinger, D., and Weber, B. (2020) Global trends in clinical trials involving pluripotent stem cells: A systematic multi-database analysis, NPJ Regenerative Medicine, 5: 15.CrossRefGoogle ScholarPubMed
Demouchel, P. (2015) The Barren Sacrifice. An Essay on Political Violence. East Lansing: Michigan State University Press.CrossRefGoogle Scholar
Demouchel, P. (2017) Acting together in dis-harmony: Cooperating to conflict and cooperation in conflict, Studi di Sociologia, no. 4: 303–318.Google Scholar
Densford, F (2016) MassDevice: www.massdevice.com/avita-medical-eyes-japan-south-korea-for-recell/ [3/1/2024].Google Scholar
Dimitratos, P., and Plakoiyannaki, E. (2003) Theoretical foundations of an international entrepreneurial culture, Journal of International Entrepreneurship, 1: 187–215.CrossRefGoogle Scholar
Doss, M. X., and Sachinidis, A. (2019) Current challenges of iPSC-based disease modeling and therapeutic implications, Cells, 8(5): 403.CrossRefGoogle ScholarPubMed
Doval, D. C., Shirali, R, and Sinha, R. (2015) Post-trial access to treatment for patients participating in clinical trials, Perspectives in Clinical Research, 6(2): 82–85.CrossRefGoogle ScholarPubMed
Doudement, E. and Uppal, H. (2014) New opportunities for stem cells in drug discovery, Drug Discovery and Development. 1 July: https://bit.ly/3H5lYN1 [3/1/2024].Google Scholar
Dulak, J., and Pecyna, M. (2023) Unproven cell interventions in Poland and the exploitation of European Union law on advanced therapy medicinal products, Stem Cell Reports, 18(8): 1610–1620.CrossRefGoogle Scholar
Dumit, J., (2012a) A digital image of the category of person. In Good, B. J., Fischer, M. J., Willen, S. S. and DelVecchio Good, M.-J. (eds.) A Reader in Medical Anthropology: Theoretical Trajectories, Emergent Realities. Malden, MA: Wiley-Blackwell, 365–376.Google Scholar
Dumit, J. (2012b) Drugs for Life. How Pharmaceutical Companies Define Our Health. Durham: Duke University Press.Google Scholar
Dupuy, J.-P. (2014) Economy and the Future. East Lansing: Michigan State University.Google Scholar
Duster, T. Race and reification in science, Science, 307:1050–1051.CrossRefGoogle Scholar
Dutton, G (2007) Stem cell firms struggle for financing, Gen. 1 September: www.genengnews.com/gen-articles/stem-cell-firms-struggle-for-financing/2217/ [3/1/2024].Google Scholar
Dzierlega, K., and Yokota, T. (2020) Optimization of antisense-mediated exon skipping for Duchenne muscular dystrophy, Gene Therapy, 27: 407–416.CrossRefGoogle ScholarPubMed
EBE (European Biopharmaceutical Enterprises) (2011) EBE position paper on the hospital exemption: https://health.ec.europa.eu/system/files/2016-11/07_1_pc_atmp_2013_0.pdf [3/1/2024].Google Scholar
EBISC (2022) European Bank for Induced pluripotent Stem Cells (EBiSC): https://ebisc.org/ [3/1/2024].Google Scholar
Edgington, D. (2008) The Japanese innovation system: University-industry linkages, small firms and regional technology clusters, Promotheus 26(1): 1–19.Google Scholar
Eguizabal, C., Aran, B., Chuva de Sousa Lopes, S. M., Geens, M., Heindryckx, B., Panula, S., Popovic, M., Vassena, R., and Veiga, A. (2019) Two decades of embryonic stem cells: A historical overview, Human Reproduction Open, 1: https://doi.org/10.1093/hropen/hoy024 [3/1/2024].Google Scholar
Ellul, J. (1964) The Technological Society. New York: Vintage Books.Google Scholar
EMA (2013) Stem cell therapy treatments. 22 April: www.ema.europa.eu/en/news/stem-cell-therapy-treatments [3/1/2024].Google Scholar
EMA (2014) European Medicines Agency launches adaptive licensing pilot project, 19 March 2014, EMA/430892/2013: https://bit.ly/48GNLPQ [3/1/2024].Google Scholar
EMA (2018) Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME), EMA/CHMP/57760/2015, Rev. 1. 7 May: www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines [3/1/2024].Google Scholar
EMA (2021) Advanced Therapy Classification: www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification [3/1/2024].Google Scholar
Epstein, S. (1995) The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials, Science, Technology and Human Values, 20(4): 408–437.CrossRefGoogle ScholarPubMed
Epstein, S. (1996) Impure Science: AIDS, Activism and the Politics of Knowledge. Berkeley: University of California Press.Google ScholarPubMed
Eriksson, L., and Webster, A. (2008) Standardizing the unknown: Practicable pluripotency as doable futures, Science as Culture, 17(1): 57–69.CrossRefGoogle Scholar
Esposito, R. (2011) Immunitas. The Protection and Negotiation of Life. Maiden: Polity Press.Google Scholar
Etzkowitz, H., and Leydesdorff, L (2000) The dynamics of innovation: From National Systems and ‘Mode 2’ to a triple helix of university – industry – government relations, Research Policy, 29(2): 109–123.CrossRefGoogle Scholar
Eurekalert (2009) Stem cell research: www.eurekalert.org/pub_releases/2009-07/sicp-scr072809.php [3/1/2024].Google Scholar
European Parliament (2007) Regulation (EC) No 1394/2007 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. 13 November: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF [3/1/2024].Google Scholar
European Parliament (2020) Factsheets on the European Union. The subsidiarity principle: www.europarl.europa.eu/factsheets/en/sheet/7/the-principle-of-subsidiarity [3/1/2024].Google Scholar
Eurostemcell (2022) Explore stem cells: www.eurostemcell.org/stem-cells [3/1/2024].Google Scholar
European Commission (2014) Report from the Commission to the European Parliament and the Council, Brussels, 28 March 2014 COM(2014) 188 final, 7–8: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2014:0188:FIN:EN:PDF [3/1/2024].Google Scholar
EUSPR (2023) European Society for Prevention Research: https://euspr.org/category/featured-projects/ [3/1/2024].Google Scholar
Expresspharma (2020) Stempeutics India and Novumcella Japan to work on development co-operation of Stempeucel product for Japanese market, Expresspharma. 1 June: www.expresspharma.in/stempeutics-india-and-novumcella-japan-to-work-on-development-co-operation-of-stempeucel-product-for-japanese-market/ [3/1/2024].Google Scholar
Fanelli, D. (2010) Do pressures to publish increase scientists’ bias? An empirical support from US States data, PLoS One, 5: e10271.CrossRefGoogle ScholarPubMed
Fantom, N., Fu, H. S., Prince, W. C. (2014) LICs, LMICs, UMICs, and HICs: classifying economies for analytical purposes: https://blogs.worldbank.org/opendata/lics-lmics-umics-and-hics-classifying-economies-analytical-purposes [3/1/2024].Google Scholar
Farmer, P. (2010) Partner to the Poor: A Paul Farmer Reader. Edited by Saussey, H.. Berkeley: University of California Press.Google Scholar
Faulkner, A. (2012a) Law’s performativities: Shaping the emergence of regenerative medicine through European Union legislation, Social Studies of Science, 42(5): 753–774.CrossRefGoogle ScholarPubMed
Faulkner, A. (2012b) Tissue engineered technologies: Regulatory pharmaceuticalisation in the European Union, INNOVATION: The European Journal of Social Science Research, 25 (4) 389–408.Google Scholar
Faulkner, A. (2019) Special treatment? Flexibilities in the politics of regenerative medicine’s gatekeeping regimes in the UK, Science as Culture, 28(2): 149–173.CrossRefGoogle Scholar
Faulkner, A., and Poort, L. (2017) Stretching and challenging the boundaries of law: Varieties of knowledge in biotechnologies regulation, Minerva 55(2): 209–228.CrossRefGoogle Scholar
Feenberg, A. (1988) Fetishism and form: Erotic and economic disorder in literature. In Dumouchel, P. (ed.) Violence and Truth. Stanford: Stanford University Press, 134–151.Google Scholar
FIRM (2012) Saisei iryou sangyouka sokushin e no kadai (再生医療産業化促進への課題 [Issues in accelerating the commercialization of regenerative medicine]), presentation by the Forum for Innovative Regenerative Medicine to Cabinet Committee on Regulation and Reform. 29 November: www.cao.go.jp/sasshin/kisei-seido/meeting/2012/togi/life/121129/item2.pdf [3/1/2024].Google Scholar
FIRM (2018) The 1st Asia Partnership Conference of Regenerative Medicine Associations, Nihonbashi. 29 April: https://firm.or.jp/apacrm/ [3/1/2024].Google Scholar
Fisher, J. A. (2007) Coming soon to a physician near you: Medical neoliberalism and pharmaceutical clinical trials. Harvard Health Policy Review: A Student Publication of the Harvard Interfaculty Initiative in Health Policy, 8(1): 61–70.Google Scholar
Fisher, J. A. (2009) Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. New Brunswick, NJ: Rutgers University Press.Google Scholar
Foong, P. (2018) Stemming the tide of unproven autologous stem cell therapies in Australia, UNSW Law Journal, no 3: www.unswlawjournal.unsw.edu.au/forum_article/stemming-the-tide-of-unproven-autologous-stem-cell-therapies-in-australia [3/1/2024].Google Scholar
Forda, S., Bergström, R., Chlebus, M., Barker, R., and Høngaard Andersen, P. (2013). Priorities for improving drug research, development and regulation, Nature Reviews Drug Discovery, 12: 247–248.CrossRefGoogle ScholarPubMed
Foucault, M. (2003) Abnormal: Lectures at the College De France 1974–1975. Edited by Davidson, A. I.. New York: Picador.Google Scholar
Freeman, G., and Swidlicki, P. (2014) The EU impact on the UK life science sector: www.eufreshstart.org/downloads/lifesciences2.pdf.Google Scholar
Freitag, J., Wickham, J., Shah, K., Li, D., Norsworthy, C., and Tenen, A. (2020) Mesenchymal stem cell therapy combined with arthroscopic abrasion arthroplasty regenerates cartilage in patients with severe knee osteoarthritis: A case series, Regenerative Medicine, 15(8): 1957–1977.CrossRefGoogle ScholarPubMed
Fukuyama, F. (2004) The imperative of state building, Journal of Democracy, 15(2): 17–31.CrossRefGoogle Scholar
Galtung, J. (1969) Violence, peace, and peace research, Journal of Peace Research, 6(3): 167–191.CrossRefGoogle Scholar
Gardner, J. (2017) Distributive justice and regenerative medicine, Regenerative Medicine, 12(7): 865–874.CrossRefGoogle ScholarPubMed
Gawande, A. (2015) Being Mortal. Illness, Medicine, and What Matters in the End. London: Profile Books.Google Scholar
Ghinea, N., Munsie, M., Rudge, C., and Stewart, C. (2020) Australian regulation of autologous human cell and tissue products: Implications for commercial stem cell clinics, Regenerative Medicine, 15(2): 1361–1369.CrossRefGoogle ScholarPubMed
Gieryn, T. (1983) Boundary-work and the demarcation of science from non-science: Strains and interests in professional ideologies of scientists, American Sociological Review, 48: 781–795.CrossRefGoogle Scholar
Gilbert, N., and Mulkay, M. (1984) Opening Pandora’s Box: A Sociological Analysis of Scientists’ Discourse. Cambridge: Cambridge University Press.Google Scholar
Girard, R. (1986) The Scapegoat. Baltimore: John Hopkins University Press.Google Scholar
Girard, R. (2000) Violence Renounced. In Swartley, W. (ed.) Violence Renounced: René Girard, Biblical Studies, and Peacemaking. Telford, PA: Pandora Press, 308–319.Google Scholar
Girard, R. (2016) Things Hidden Since the Foundation of the World. London; New York: Bloomsbury.Google Scholar
Girard, R. (2020 [1977]) Violence and the Sacred. Translated by P. Gregory. London; New York: Bloomsbury.Google Scholar
Glass, K. C.(2006) Questions and challenges in the governance of research involving humans: A Canadian perspective. In Lemmens, T. and Waring, D. (eds.) Law and Ethics in Biomedical Research: Regulation, Conflict of Interest and Liability. Toronto: University of Toronto Press, 35–41.Google Scholar
Global News Wire (2015) The Alliance for Regenerative Medicine enters into memorandum of understanding with Japan’s Forum for Innovative Regenerative Medicine (Press Release ARM). 12 March: https://bit.ly/3vq8Q2E [3/1/2024].Google Scholar
Görg, C., and Brand, U. (2006) Contested regimes in the international political economy: Global regulation of genetic resources and the internationalization of the State, Global Environmental Politics, 6(4): 101–123.CrossRefGoogle Scholar
Gottweis, H., Salter, B., and Waldby, C. (2009) The Global Politics of Human Embryonic Stem Cell Science. Basingstoke: Palgrave Macmillan.CrossRefGoogle Scholar
GSCRMA (2017) 广州干细胞与再生医学联盟 [Guangzhou ganxibao yu zaishengyixue lianmeng (Guangzhou Stem Cell and Regenerative Medicine Alliance)]: www.gibh.cas.cn/ydhz/hzdt/200908/t20090807_2352362.html [3/1/2024].Google Scholar
Guangzhou Shengwu-Yiyaowang (2014) 广州生物医药王 [Guangzhou Shengwu YiyaoWang]: www.gzbio.org/ [16/2/2016].Google Scholar
Gunter, K. C., Caplan, A. L., Mason, C., Salzman, R., Janssen, W.E.,et al. (2010) Cell therapy medical tourism: Time for action (ISCT White Paper) Cytotherapy, 12: 965–968: www.isct-cytotherapy.org/article/S1465-3249(10)70464-3/fulltext [3/1/2024].10.3109/14653249.2010.532663CrossRefGoogle Scholar
Guston, D. H. (2000) Retiring the social contract for science, Issues in Science and Technology, xvi(4): https://issues.org/p_guston/ [3/1/2024].Google Scholar
Haas, P. (1992) Epistemic communities and international policy coordination, International Organization, 46(1): 1–35.CrossRefGoogle Scholar
Hagstrom, W. O. (1974) Competition in science, American Sociological Review, 39(1): 1–18.CrossRefGoogle Scholar
HanShi, Lianhe (2011) Health & Biotech: www.health-biotech.com/en/com-news-detail009.html [7/3/2017].Google Scholar
Haraway, D. (2013) The biopolitics of postmodern bodies: Constitutions of Self in immune system discourse. In Campbell, T. and Sitze, A. (eds.) Biopolitics: A Reader. Durham: Duke University Press, 274–309.Google Scholar
Hargreaves, B. (2019) ‘Can you manufacture consistently?’ The big question in regenerative medicine, BioPharma: www.biopharma-reporter.com/Article/2019/03/11/State-of-the-regenerative-medicine-industry [3/1/2024].Google Scholar
Harmon, S., and Kale, D. (2015) Regulating in developing countries: Multiple roles for medical research and products regulation in Argentina and India, Technology in Society, 43: 10–22.10.1016/j.techsoc.2015.07.002CrossRefGoogle Scholar
Harrington, J., and Hauskeller, C. (2014) Translational research: An imperative shaping the spaces in biomedicine, TECNOSCIENZA, AnItalian Journal of Science & Technology Studies, 4(2): 73–91.Google Scholar
Harris, J. (2005) Scientific research is a moral duty, Journal of Medical Ethics, 31(4): 242–248.CrossRefGoogle ScholarPubMed
Haslam, D. (2022) Side Effects: How our Healthcare Lost Its Way. London: Atlantic Books.Google Scholar
Hauskeller, C., Baur, N., and Harrington, J. (2017) Standards, harmonization and cultural differences: Implementation of a European stem cell clinical trial, Science as Culture, 28(2): 174–199.CrossRefGoogle Scholar
Hauskeller, C. (2018) Between the local and the global: Evaluating European regulation of stem cell regenerative medicine, Perspective in Biology and Medicine, 61(1): 42–58.CrossRefGoogle ScholarPubMed
Hayden, E. C. (2014) Activists sound alarm on tiered drug prices, Nature, 509: 412.CrossRefGoogle ScholarPubMed
Herrin, C. (2020) Government health care restrictions are costing lives, The Hill. 30 June: https://thehill.com/opinion/healthcare/505257-government-health-care-restrictions-are-costing-lives [3/1/2024].Google Scholar
HHP (2014) Overview of the plan for promotion of medical research and development: www.kantei.go.jp/jp/singi/kenkouiryou/en/pdf/plan.pdf [3/1/2024].Google Scholar
Hills, A., Awigena-Cook, J., Genenz, K., Ostertag, M., Butler, S., Eggimann, A.V., and Hubert, A. (2020) An assessment of the hospital exemption landscape across European Member States: Regulatory frameworks, use and impact, Cytotherapy, 22(12): 772–779.e1: www.isct-cytotherapy.org/article/S1465-3249(20)30847-1/fulltext [3/1/2024].CrossRefGoogle ScholarPubMed
Hishiyama, Y. (2010) Raifu-Saiensu Seisaku no Genzai (ライフサイエンス政策の現在 [The Current State of Life-Science Policy]). Tokyo: Keiso Shobo.Google Scholar
HISO (Health Information Systems Office) HISO report: www.hiso.or.th/hiso5/report/download.php?name=eng2010_22 [3/1/2024].Google Scholar
Holbein, M. E. B., Berglund, J. P., Weatherwax, K., Gerber, K. E., and Adamo, J. A. (2015) Access to investigational drugs: FDA expanded access programs or ‘right-to-try’ legislation?, Clinical and Translational Science (CTS), 8(5): www.ncbi.nlm.nih.gov/pmc/articles/PMC4503515/ [3/1/2024].Google ScholarPubMed
Holistic Medical Centre (2022) Holistic Medical Centre: www.holistic-medical.com/ [3/1/2024].Google Scholar
Hong, S. (2008) The Hwang scandal that ‘shook the world of science’, East Asian Science, Technology and Society: An International Journal, 2(1): 1–7.10.1215/s12280-008-9041-xCrossRefGoogle Scholar
House of Lords (2013) Science and technology select committee regenerative medicine oral and written evidence: www.parliament.uk/documents/lords-committees/science-technology/RegenerativeMedicine/RegenMed.pdf [3/1/2024].Google Scholar
hPSCReg (2022) About hPSCReg: https://hpscreg.eu/about [3/1/2024].Google Scholar
Huang, H., Young, W., Skaper, S., Chen, L., Moviglia, G., et al. (2019) Clinical neurorestorative therapeutic guidelines for spinal cord injury (IANR/CANR version 2019), Journal of Orthopedic Translation, 20: 14–24.CrossRefGoogle ScholarPubMed
Hunt, P., and Khosla, R. (2010) Are drug companies living up to their human rights responsibilities? The perspective of the former United Nations Special Rapporteur (2002–2008), PLoS Med, 7(9): e100030: https://doi.org/10.1371/journal.pmed.1000330 [3/1/2024].CrossRefGoogle ScholarPubMed
Hyun, I. (2010) Allowing innovative stem cell–based therapies outside of clinical trials: Ethical and policy challenges, Journal of Law, Medicine & Ethics, Summer: 277–285.CrossRefGoogle Scholar
IANR (2021) The International Association for Neurorestoratology: www.ianr.org.cn/ [3/1/2024].Google Scholar
IBRI (2015) 滲出型加齢黄斑変性に対する自家 iPS 細胞由来網膜色素上皮シート移植に関する臨床研究における被験者募集について [Shinshutsu-gata kareiōhanhensei ni taisuru jika iPS saibō yurai mōmaku shikisojōhi shīto ishoku ni kansuru rinshō kenkyū’ ni okeru hikensha boshū ni tsuite (Recruitment of subjects for clinical research on autologous iPS cell-derived retinal pigment epithelium sheet transplantation for wet age-related macular degeneration)]: www.riken.jp/pr/news/2013/20130730_1/ [3/1/2024].Google Scholar
ICH (2016) Welcome to the ICH official website: www.ich.org/home.html [03/01/2024]Google Scholar
ICMR-DBT (Indian Council of Medical Research-Department of Biotechnology) (2007) Guidelines for stem cell research and therapy. Director General ICMR, New Delhi: https://main.icmr.nic.in/sites/default/files/guidelines/stem_cell_guidelines_2007_0.pdf [3/1/2024].Google Scholar
ICMR-DBT (Indian Council of Medical Research-Department of Biotechnology) (2013) National guidelines for stem cell research. Director General ICMR, New Delhi: www.ncbs.res.in/sites/default/files/policies/NGSCR%202013.pdf [3/1/2024].Google Scholar
ICMR-DBT (Indian Council of Medical Research-Department of Biotechnology) (2017) National guidelines for stem cell research. Director General ICMR, New Delhi: https://dbtindia.gov.in/regulations-guidelines/guidelines/national-guidelines-stem-cell-research-%E2%80%93-2017 [3/1/2024].Google Scholar
ICMS (2013) ICMS guidelines: www.cellmedicinesociety.org/icms-guidelines [3/1/2024].Google Scholar
ICSCN (2014) White Paper: www.stemcellconsortium.org/uploads/documents/Montreal_White_Paper.pdf [10/5/2017].Google Scholar
ICSF (2010) International Stem Cell Forum: https://stemcellforum.org/.Google Scholar
Ida, R. (2002) Ethical questions of the human embryonic stem cells research, RinshoShinkeigaku [Clinical Neurology], 42(11): 1147–1148.Google ScholarPubMed
IH (Institute for Hematology) (2014) Institute for Hematology: www.chinablood.com.cn/english/ [10/1/2016].Google Scholar
Intec (2014) 北京英智康复医院 [Beijing Yingzhi kangfu yiyuan (Beijing Yingzhi rehabilitation hospital)]: www.incarehab.com [3/1/2024].Google Scholar
Ioannidis, J. P. (2011) An epidemic of false claims: Competition and conflicts of interest distort too many medical findings, Scientific American, 304: 16.CrossRefGoogle ScholarPubMed
Iijima, H., Isho, T., Kuroki, H., Takahashi, M., and Aoyama, T. (2018) Effectiveness of mesenchymal stem cells for treating patients with knee osteoarthritis: A meta-analysis toward the establishment of effective regenerative rehabilitation, NPJ Regenerative Medicine, 3: 15.10.1038/s41536-018-0041-8CrossRefGoogle ScholarPubMed
Iijima, K., Arai, H., Akishita, M., Endo, T., Ogasawara, K., Kashihara, N., Hayashi, Y. K., Yumura, W., Yokode, M., and Ouchi, Y. (2021) Toward the development of a vibrant, super-aged society: The future of medicine and society in Japan. Geriatrics, Gerontology, International Journal, 21(8): 601–613.CrossRefGoogle Scholar
Inkwood (2021) Australia and New Zealand stem cell market forecast 2022–2028: https://inkwoodresearch.com/reports/australia-and-new-zealand-stem-cell-market/ [3/1/2024].Google Scholar
Isasi, R., Ginoza, M., Jongsma, K., and Morris, L. (2022) Mending the gaps: Ethically sensitive cells and the evolution of European stem cell policy, Regenerative Medicine, 17(8): https://doi.org/10.2217/rme-2022-0043 [3/1/2024].CrossRefGoogle Scholar
ISCBI (2010) International Stem Cell Banking Initiative: http://stemcellforum.org/forum_initiatives/international_stem_cell_banking_initiative.cfm.Google Scholar
ISCR (2012) International Stem Cell Registry: www.umassmed.edu/iscr/ [4/3/2019].Google Scholar
ISCT (2015) Regulatory, quality and operations resources: www.celltherapysociety.org/?page=CommunityResources [4/3/2019].Google Scholar
ISSCR (2008) Guidelines for the clinical translation of stem cells: www.isscr.org/docs/guidelines/isscrglclinicaltrans.pdf [10/5/2023].Google Scholar
ISSCR (2016) Guidelines for stem cell research and clinical translation: www.isscr.org/docs/default-source/guidelines/isscr-guidelines-for-stem-cell-research-and-clinical-translation.pdf?sfvrsn=2 [10/5/2023].Google Scholar
ISSCR (2017) Dear Dr. VijayRaghavan: www.isscr.org/docs/default-source/policy-documents/vijayraghavan-letter-final-6617.pdf?sfvrsn=2%20%5Blast%20accessed%20June%202021%5D [8/6/2021].Google Scholar
ISSCR (2019) ISSCR. Letter Doug Melton: www.isscr.org/docs/default-source/policy-documents/isscr-comments-re-china’s-somatic-cell-therapy-rules-20-may-2019.pdf?sfvrsn=2 [8/6/2021].Google Scholar
IWA (2017) Prudent healthcare: A turning point for health and care in Wales: https://bit.ly/48CgbK [3/1/2024].Google Scholar
Jasanoff, S. (2019) Can Science Make Sense of Life? Cambridge: Polity Press.Google Scholar
JLT (1948) Medical Practitioner’s Act. Act No. 201 of July 30: www.japaneselawtranslation.go.jp/law/detail/?ft=1&re=2&dn=1&x=59&y=13&co=01&ia=03&ja=04&ky=medical+practitioner%5C%27s+act&page=6 [3/1/2024].Google Scholar
JSRM (2015) Regenerative therapy by fusion of medicine and engineering: First-in-human clinical trials with induced pluripotent stem cellsand cell sheet technology, Regenerative Therapy, 2: 2–5: www.sciencedirect.com/science/article/pii/S2352320415000255 [3/1/2024].CrossRefGoogle Scholar
JSRM (2016) Yokohama Declaration: www.linkedin.com/company/jsrm [3/1/2024]Google Scholar
JST (2008)オールジャパン体制の構築に向けた 文部科学省のiPS細胞研究等の推進体制 [Ōrujapan taisei no kōchiku ni muketa bun bukagakushō no iPS saibō kenkyū-tō no suishin taisei (Promotion system for iPS cell research, etc. by the Ministry of Education, Culture, Sports, Science and Technology to build an all-Japan system)]: www.jst.go.jp/keytech/h20-1sanko.pdf [3/1/2024].Google Scholar
JST (2021) Japan Science and Technology Agency (JST). Overview: www.jst.go.jp/EN/about/overview.html [3/1/2024].Google Scholar
JSTA (2015) Research Center Network for Realization of Regenerative Medicine: www.jst.go.jp/saisei-nw/en/ [3/1/2024].Google Scholar
J-Tec (2021) History: www.jpte.co.jp/english/about_us/history.html [3/1/2024].Google Scholar
Johnson, C. (1982) MITI and the Japanese Economic Miracle: The Growth of Industrial Policy, 1925–1975. Stanford: Stanford University Press.CrossRefGoogle Scholar
Johnson, M. (2010) The cell peddlers – dealing hope to desperate families. Journal Sentinel. 1 February: www.jsonline.com/watchdog/watchdogreports/83179987.html [3/1/2024].Google Scholar
Jones, M. V., Wheeler, C., and Dimitratos, P. (2011) International Entrepreneurship in the Life Sciences. Cheltenham; Northampton: Edward Elgar.CrossRefGoogle Scholar
Jordana, J., and Levi-Faur, D. (eds.) (2004), The Politics of Regulation: Examining Regulatory Institutions and Instruments in the Governance Age. Cheltenham; Northampton: Edward Elgar.CrossRefGoogle Scholar
Jourdan, A. (2016) False hope? China’s military hospitals offer illegal experimental cures, Life. 11 July: www.reuters.com/article/us-china-hospitals-insight-idUSKCN0ZR0BW [3/1/2024].Google Scholar
Jovic, D., Yu, Y., Wang, D., Wang, K., Li, H., Xu, F., Liu, C., Liu, J., and Luo, Y. (2022) A brief overview of global trends in MSC-based cell therapy, Stem Cell Review Reports, 18(5):1525–1545.CrossRefGoogle ScholarPubMed
Kahn, N. 2015. Regenerative medicine to get boost from deregulation in Japan, The Japan Times. 3 September: www.japantimes.co.jp/news/2015/09/03/national/science-health/regenerative-medicine-get-boost-deregulation-japan/#.V0w0tUtLpg0 [3/1/2024].Google Scholar
Kalyvas, S. N. (2019) The landscape of political violence. In Chenoweth, E.., et al. (eds.) The Oxford Handbook of Terrorism. Oxford: Oxford University Press, 11–33.Google Scholar
Kami, D., Watakabe, K., Yamazaki-Inoue, M., et al. 2013. Large-scale cell production of stem cells for clinical application using the automated cell-processing machine, BMC Technology, 13(102): www.biomedcentral.com/1472-6750/13/102 [3/1/2024].Google ScholarPubMed
Kanagawa Prefecture (2016) Life innovation in Keihin coastal areas: https://bit.ly/3S3iTDn [3/1/2024].Google Scholar
Kantei (2013) 新たな医療分野の研究開発体制について [Aratana iryō bun’ya no kenkyū kaihatsu taisei ni tsuite (About R & D system in new medical field)]: www.kantei.go.jp/jp/singi/kenkouiryou/suisin/kettei/taisei.pdf [3/1/2024].Google Scholar
Kato, M., and Sleeboom-Faulkner, M. (2018) Motivations for seeking experimental treatment in Japan, Biosocieties, 13(1): 255–275.10.1057/s41292-017-0067-yCrossRefGoogle Scholar
Kawakami, M., Sipp, D., and Kato, K. (2010) Regulatory impacts on stem cell research in Japan, Cell Stem Cell, 6: 415–416.10.1016/j.stem.2010.04.010CrossRefGoogle ScholarPubMed
Kawasaki (undated) Brochure: https://global.kawasaki.com/en/industrial_equipment/medicals/auto_culture/clinical.html [28/5/2018].Google Scholar
Kawasaki (2016) Cells cultured by automation are used for a world-first clinical study in Thailand (press release): https://global.kawasaki.com/en/corp/newsroom/news/detail/?f=20161227_5800 [3/1/2024].Google Scholar
Keating, P., and Cambrosio, A. (2000) Biomedical platforms, Configurations, 8(3): 337–387.CrossRefGoogle Scholar
Keating, P., and Cambrosio, A. (2003) Biomedical Platforms. Cambridge, MA: MIT Press.CrossRefGoogle Scholar
Keck, M., and Sikkink, K. (1998) Activists beyond Borders: Advocacy Networks in International Politics. Ithaca, NY: Cornell University Press.Google Scholar
Kencare (2016) Kencare holdings: www.kencare.com.sg/kencare-holdings [3/1/2024].Google Scholar
Kiatpongsan, S, and Sipp, D. (2008) Offshore stem cell treatments, Nature Reports Stem Cells: www.nature.com/articles/stemcells.2008.151 [3/1/2024].CrossRefGoogle Scholar
Kiatpongsan, S., and Sipp, D. (2009) Monitoring and regulating offshore stem cell treatments, Science, 323, 1564–1565.CrossRefGoogle Scholar
Kim, B.-H., and Kim, M.-N. (2020) New drug act poses more regulatory setbacks for Korean bio companies, Pulse: https://pulsenews.co.kr/view.php?year=2020&no=849881 [3/1/2024].Google Scholar
Kimbrel, E. A., and Lanza, R. (2020) Next-generation stem cells – ushering in a new era of cell-based therapies, Nature Reviews Drug Discovery, 19: 463–479.CrossRefGoogle Scholar
Kingsbury, B., Malone, D. M., Mertenskötter, P., Stewart, R. B., Streinz, T., and Sunamin, A. (2019) Megaregulation: Global Economic Ordering after TPP. Oxford: Oxford University Press.CrossRefGoogle Scholar
Kleiderman, E., Boily, A., and Hasilo, C., et al. (2018) Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials, Stem Cell Research & Therapy, 9: 307.CrossRefGoogle ScholarPubMed
Knoepfler, P. S. (2015) Landmark IPSC clinical study on hold due to genomic issue, The Niche.1 July: https://ipscell.com/2015/07/firstipscstop/ [3/1/2024].Google Scholar
Knoepfler, P. S. (2017) The stem cell hard sell: Report from a clinic’s patient recruitment seminar, Stem Cells Translational Medicine, 6(1): 14–16: https://doi.org/10.5966/sctm.2016-0208 [3/1/2024].CrossRefGoogle ScholarPubMed
Krimsky, S. (2006) The ethical and legal foundations of scientific ‘conflict of interest’. In Lemmings, T. and Waring, D. W. R. (eds.) Law and Ethics in Biomedical Research. Toronto: University of Toronto Press, chapter 4.Google Scholar
Kumamoto University (2011) Shittoku! Nattoku! Duchennegatakinjisutorofii no kokusai kyōdōchiken ni tsuite [in Japanese] (Good to know! On the global clinical trials for Duchenne Muscular Dystrophy), Kumamoto University Hospital News, 10: 4.Google Scholar
Kurata, K., and Choi, Y.-H. (2012) Dissemination of regenerative medicine in Japan: Promoting commercialization under the regulatory system, The Research Institute of Economy, Trade and Industry, January: www.rieti.go.jp/jp/publications/dp/12e004.pdf [3/1/2024].Google Scholar
Lahiry, S., Chaudhury, S., Sinha, R, and Chatterjee, S. (2019) The national guidelines for stem cell research (2017): What academicians need to know?, Perspectives in Clinical Research, 10:148–154: www.ncbi.nlm.nih.gov/pmc/articles/PMC6801994/ [3/1/2024].CrossRefGoogle ScholarPubMed
Lambert, H. (2006) Accounting for EBM: Notions of evidence in medicine, Social Science and Medicine, 62: 2633–2645.10.1016/j.socscimed.2005.11.023CrossRefGoogle ScholarPubMed
Landfeldt, E., Lindgren, P., Bell, C. F., Schmitt, C., Guglieri, M., Straub, V., Lochmüller, H., and Bushby, K. (2014) The burden of Duchenne muscular dystrophy: An international, cross-sectional study, Neurology, 83(6): 529–536.CrossRefGoogle ScholarPubMed
Landzelius, K. (2006) Introduction: Patient organization movements and new metamorphoses in patienthood, Social Science & Medicine, 62: 529–537.CrossRefGoogle ScholarPubMed
Larkin, J. (2003) Strategic Reputation Risk Management. New York: Palgrave MacMillan.CrossRefGoogle Scholar
Latour, B. (1993) We Have Never Been Modern. Cambridge, MA: Harvard University Press.Google Scholar
Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., Menon, D., and Caulfield, T. (2008) Stem cell clinics online: The direct-to-consumer portrayal of stem cell medicine, Cell Stem Cell, 3: 591–594.CrossRefGoogle ScholarPubMed
L.A.W. (2015) Overview of the Foreign Contribution Regulation Act in India: www.lexology.com/library/detail.aspx?g=f86ace93-2a47-4ed0-a88a-d54912e1c0e0 [3/1/2024].Google Scholar
Leach, M., Scoones, I., and Wynne, B. (eds.) (2005) Science and Citizens: Globalization and the Challenge of Engagement, Claiming Citizenship: Rights, Participation and Accountability Series. London; New York: Zed Books.Google Scholar
Lee, K. M., Han, Y., Yoon, J., Lee, S., and Lee, J. I. (2015) New governmental regulatory system for regenerative medicine in Japan, Tissue Engineering and Regenerative Medicine, 12: 167–172.10.1007/s13770-015-0435-2CrossRefGoogle Scholar
Lee, T. L., and Lysaght, T. (2017) Adaptive pathways regulations for stem cells: Accelerating access to medicine or deregulating access to markets?, Scripted, 14(1): 81–99.CrossRefGoogle Scholar
Lemmens, T., and Waring, D. R. (2006) Introduction. In Lemmens, T. and Waring, D. R. (eds.) Law and Ethics in Biomedical Research. Regulation, Conflict of Interest and Liability. Toronto: University of Toronto Press.10.3138/9781442676596CrossRefGoogle Scholar
Lesyuk, W., Kriza, C., and Kolominsky-Rabas, P. (2018) Cost-of-illness studies in heart failure: A systematic review 2004–2016, BMC Cardiovasc Disord, 18: 74: https://doi.org/10.1186/s12872-018-0815-3 [3/1/2024].CrossRefGoogle ScholarPubMed
Levi-Faur, D (2005a) The global diffusion of regulatory capitalism, Annals of the American Academy of Political and Social Science, 598(1): 12–32.CrossRefGoogle Scholar
Levi-Faur, D. (2005b) Regulatory capitalism: The dynamics of change beyond telecoms and electricity, Governance, 19(3): 497–525.CrossRefGoogle Scholar
Levi-Faur, D. (2005c) The global diffusion of regulatory capitalism, The Annals of the American Academy of Political and Social Science, 598: 12–32.10.1177/0002716204272371CrossRefGoogle Scholar
Levine, A. D. (2008) Identifying under- and over-performing countries in research related to human embryonic stem cells, Cell Stem Cell, 2, 521–524.CrossRefGoogle Scholar
Li, Y., Verter, F., Wang, B., and Ning, G. (2019) Regulations on cell therapy products in China: A brief history and current status, Regenerative Medicine, 14(8): 791–803.CrossRefGoogle Scholar
Lim, J.-Y. (2020) Bio firms hope for faster research with ‘Cheomsaeng’ law in August, The Korean Herald. 13 July: www.koreaherald.com/view.php?ud=20200713000831&ACE_SEARCH=1 [3/1/2024].Google Scholar
Lim, L. (2008) Stem-cell therapy in China draws foreign patients: www.npr.org/templates/story/story.php?storyId=88123868 [3/1/2024].Google Scholar
Lindvall, O., and Hyun, I. (2009) Medical innovation versus stem cell tourism, Science, 324: 1664–1665.10.1126/science.1171749CrossRefGoogle ScholarPubMed
Lindsay, J. O., Allez, M., Clark, M., Labopin, M., Ricart, E., et al. (2017) Autologous stem-cell transplantation in treatment-refractory Crohn’s disease: An analysis of pooled data from the ASTIC trial, Lancet Gastroenterology Hepatology, 2(6): 399–406. doi:10.1016/S2468-1253(17)30056-0.CrossRefGoogle ScholarPubMed
Liu, X., Li, W., Fu, X., and Xu, Y. (2017) The immunogenicity and immune tolerance of pluripotent stem cell derivatives, Frontiers in Immunology, 8: https://doi.org/10.3389/fimmu.2017.00645 [3/1/2024].CrossRefGoogle ScholarPubMed
Locke, J. (2007[1690]) Second treatise of government. In Sandel, M. (ed.) Justice. A Reader. Oxford: Oxford University Press, 83–126.Google Scholar
Lowdell, M. W., Birchall, M., and Thrasher, A. J. (2012) Use of compassionate case ATMP in preclinical data for clinical trial applications, Lancet, 379: 2341.CrossRefGoogle ScholarPubMed
Lyn, T. E. (2011) China ‘stem cell therapies’ offer heartbreak to many, Reuters. 21 September: www.reuters.com/article/idUSTRE78K181/ [3/1/2024].Google Scholar
Lysaght, T. (2017) Accelerating regenerative medicine: The Japanese experiment in ethics and regulation, Regenerative Medicine, 12(6): 657–668.CrossRefGoogle ScholarPubMed
Madden, B. (2010) Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering. Arlington Heights: The Heartland Institute.Google Scholar
Madden, B. (2017) Free to choose medicine, Powerpoint Presentation. 16 September: https://ssrn.com/abstract=3038163 [3/1/2024].CrossRefGoogle Scholar
Madrid, M., Sumen, C., Aivio, S., and Saklayen, N. (2021) Autologous induced pluripotent stem cell–based cell therapies: Promise, progress, and challenges, Current Protocols, 1(3): https://doi.org/10.1002/cpz1.88 [3/1/2024].CrossRefGoogle ScholarPubMed
Magellan Stem Cells (2020) Human stem cells: www.magellanstemcells.com.au/human-stem-cells [6/5/2020].Google Scholar
Mahalatchimy, A., Rial-Sebbag, E., Tournay, V., and Faulkner, A. (2012) The legal landscape for advanced therapies: Material and institutional implementation of European Union rules in France and the United Kingdom, Journal of Law and Society, 39: 131–149.CrossRefGoogle ScholarPubMed
Majone, G. (1994) The rise of the regulatory state in Europe, West European Politics, 17(3): 77–101.CrossRefGoogle Scholar
Majone, G. (1997) From the positive to the regulatory state: Causes and consequences of changes in the mode of governance, Journal of Public Policy, 17(2), 139–167.CrossRefGoogle Scholar
Martin, E. (1994) Flexible Bodies: Tracking Immunity in American Culture from the Days of Polio to the Days of AIDS. Boston: Beacon Press.Google Scholar
Martinson, B. C., Crain, A. L., Anderson, M. S., and De Vries, R. (2009) Institutions’ expectations for researchers’ self-funding, federal grant holding, and private industry involvement: Manifold drivers of self-interest and researcher behavior, Academic Medicine, 84:1491–1499: doi:10.1097/ACM.0b013e3181bb2ca6 [3/1/2024].CrossRefGoogle ScholarPubMed
Mason, C., and Hoare, M. (2007) Regenerative medicine bioprocessing: Building a conceptual framework based on early studies, Tissue Engineering, 13(2): 301–311.CrossRefGoogle ScholarPubMed
Master, Z., Matthews, K., and Abou-El-Enein, M. (2021) Unproven stem cell interventions: A global public health problem requiring global deliberation, Stem Cell Reports, 16(6), 1435–1445: https://doi.org/10.1016/j.stemcr.2021.05.004 [3/1/2024].CrossRefGoogle Scholar
Mastroianni, A., and Kahn, J. (2006) Swinging on the pendulum: Shifting views of justice in human subjects research. In Lemmens, T. and Warinn, D. (eds.) Law and Ethics in Biomedical Research: Regulation, Conflict of Interest and Liability. Toronto: University of Toronto Press, 47–60: www.jstor.org/stable/10.3138/9781442676596.7 [3/1/2024].Google Scholar
Mathen, C., and Sinnappah-Kang, N. D. (2020) Stem cell research and therapy in India: General awareness for the public and stem cell therapy providers, CHRISMED, 7(2): 90–94: https://journals.lww.com/chri/Fulltext/2020/07020/Stem_Cell_Research_and_Therapy_in_India__General.2.aspx [3/1/2024].Google Scholar
Matoba, S., and Zhang, Y. (2018) Somatic cell nuclear transfer reprogramming: Mechanisms and applications, Cell Stem Cell, 23: 471–485.CrossRefGoogle ScholarPubMed
Matsumura, H., Harunari, N., and Ikeda, H. (2016) First experience using cultured epidermal autografts in Taiwan for burn victims of the Formosa Fun Coast Water Park explosion, as part of Japanese medical assistance, Burns, 42(3): 697–703: https://doi.org/10.1016/j.burns.2015.12.009 [3/1/2024].CrossRefGoogle ScholarPubMed
Matsuyama, A. (2008) ‘ヒト幹細胞を用いる臨床研究に関する指針’の概要 [‘hito gansaibo o yooiru rinshō kenkyū ni kansuru shosho’ no gaiyō (An overview of ‘the guideline for clinical research using human stem cells’)], 日本臨床 [Nihon Rinsoō (Japan Clinical)], 66(5): 843–849.Google Scholar
McCain, J. (2005) Does race have a place in biotechnological research?, Biotechnology Healthcare, 2(6): 54–62.Google ScholarPubMed
McCain, K. W. (1991) Communication, competition and secrecy: The production and dissemination of research-related information in genetics, Science, Technology and Human Value, 16: 491–516.CrossRefGoogle Scholar
McCullough, M. (2008) Stem-cell tourism troubles experts, Philadelphia Inquirer. 15 July: www.researchgate.net/publication/228481428_Stem-cell_tourism_troubles_experts [3/1/2024].Google Scholar
McMahon, D. (2014) The global industry for unproven stem cell interventions and stem cell tourism, Tissue Engineering and Regenerative Medicine, 11(1): 1–9.CrossRefGoogle Scholar
McMahon, D., and Thorsteinsdóttir, H. (2010) Regulations are needed for stem cell tourism: Insights from China, The American Journal of Bioethics, 10(5): 34–36.CrossRefGoogle ScholarPubMed
Meekosha, M., and Soldatic, D. (2014) Human rights discourse and the global South. In Soldatic, D. and Meekosha, M. (eds.) The Global Politics of Impairment and Disability. London; New York: Routledge.Google Scholar
Meldrum (2014) GlobeNewswire Inc: https://bit.ly/3S47lQt [3/1/2024].Google Scholar
Merton, R. K. (1957) Priorities in scientific discovery, American Sociological Review, 22: 635–659.CrossRefGoogle Scholar
MEXT (2007) iPS Saibou (Jinkō-Tanōsei Kansaibou) Kenkyu nado no kasokuni muketa Sōgō Senryaku [General Strategy to Promote iPS Cell Research]: www.lifescience.mext.go.jp/download/news/ips_senryaku.pdf [3/1/2024].Google Scholar
MEXT (2010) 再生医療の実現化プロジェクト（拡充 [Saisei iryō no jitsugen-ka purojekuto (kakujū)] [The Realisation of Regenerative Medicine Project (Extended)]: www.mext.go.jp/a_menu/hyouka/kekka/1289855.htm [3/1/2024].Google Scholar
MFDS (2013) Administrative advance notice for the revision of regulation on review and authorization of biological products (MFDS Notification No. 2013‒21, Amended on 5 April) issued on 30 April.Google Scholar
MHRA (2007) Regulation (Ec) No 1394/2007 on advanced therapy medicinal products: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF [3/1/2024].Google Scholar
MHRA (2014) Government response to the UK Early Access to Medicines Scheme consultation, March: https://assets.publishing.service.gov.uk/media/6419bd01d3bf7f7ffc14026f/Clinical_Trials_Final_government_response_to_consultation.pdf [3/1/2024].Google Scholar
Minogue, M., and Carino, L. V. (2006) Regulatory Governance in Development Countries. Cheltenham: Edward Elgar.CrossRefGoogle Scholar
MoH (2003) 人类胚胎干细胞研究的伦理指导原则 [renlei peitai ganxibao yanjiu de lunli zhidao yuanze (Ethical guiding principles on human embryonic stem cell research (No-460), promulgated by the Ministry of Science and Technology and the Ministry of Health, People’s Republic of China on December 24)]. www.most.gov.cn/fggw/zfw/zfw/2003/200512/t2005/1214_54948.htm [3/1/2024].Google Scholar
MoH (2009) 卫生部关于印发《医疗技术临床应用管理办法》的通知 [Weishengbu guanyu yinfa yiliao jishu linchuang yingyong guanli banfa de tongzhi (Clinical application of medical technology management approach)]. 16 March, no 18: www.nhc.gov.cn/yzygj/s3585u/200903/1acc529b5b7a440ea0b415cb96b84a86.shtml [3/1/2024].Google Scholar
MoH (2011) 关于开展干细胞临床研究和应用自查自纠工作的通知 [Guanyu kaizhan ganxibao linchuang yanjiu he yingyong zicha zijiu gongzuo de tongzhi (Notification on self-evaluation and self-correction work regarding the development of clinical stem cell clinical research and application)]. 16 December, no 1177: www.nhc.gov.cn/zwgkzt/pkjjy1/201201/53890.shtml [3/1/2024].Google Scholar
MoH (2012) 两家医院违法违规开展干细胞诊疗活动被通报批评 [Liang jia yiyuan weifa weigui kaizhan ganxibao huodong bei tongbao piping (Two hospitals were criticized for carrying out stem cell diagnosis and treatment activities in violation of laws and regulations)]. 13 November: www.gov.cn/jrzg/2012-11/13/content_2264690.htm [3/1/2024].Google Scholar
MoH (2013) 关于征求《干细胞临床试验研究管理办法（试行）》等文件意见的函 [Guanyu chengqiu <ganxibao linchuang shiyan yanjiu guanli banfa (shixing)> deng wenjian yijian de han (Letter regarding soliciting opinions on the ‘stem cell clinical trial research management measures (trial)’ and other documents)]. 7 March: www.nhc.gov.cn/qjjys/s3581/201501/93647e071ba04d8eafa4ed8fd3ab840a.shtml [3/1/2024].+deng+wenjian+yijian+de+han+(Letter+regarding+soliciting+opinions+on+the+‘stem+cell+clinical+trial+research+management+measures+(trial)’+and+other+documents)].+7+March:+www.nhc.gov.cn/qjjys/s3581/201501/93647e071ba04d8eafa4ed8fd3ab840a.shtml+[3/1/2024].>Google Scholar
MoST (2013) 十二五”863”计划生物和医药技术领域”干细胞治疗技术临床转化及应用研究 [Shi-er-wu ‘863’ jihua shenwu he yiyue jishu lingyu ‘ganxibao zhiliao jishu linchuanghua ji yingyong yanjiu (The domain of ‘stem cell therapy technology and vlinical translation and applied research’ of the 12th five year Plan’s ‘863’ Program for Biology and Medical Technology)]. 16 February: www.most.gov.cn/kjbgz/201205/t20120507_94184.html [3/1/2024].Google Scholar
Ministry of Commerce [商务部] (2019) 市场准入负面清单（2019年版）[Shìchǎng zhǔn rù fùmiàn qīngdān 2019 niánbǎn (market access negative list, 2019 edition)]: http://tfs.mofcom.gov.cn/article/bc/201911/20191102916059.shtml [3/1/2024].Google Scholar
Ministry of Health and Family Welfare (2019) New drugs and clinical trial rules G.S.R.227 (Hindi/English): https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf [3/1/2024].Google Scholar
Mirowski, P., and Sent, E.-M. (2002) Introduction. In Mirowski, P. and Sent, E.-M. (eds.) Science Bought and Sold: Essays in the Economics of Science. Chicago: University of Chicago Press, 1–66.Google Scholar
MoHLW (2006)人ー幹細胞を用いる臨床ー研究に感する指針 [Hito-Kansaibo wo mochiiru rinsyō-kenkyu ni kansuru sishin [Guidelines for clinical research using human stem cells)]. Enacted 1 September: www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000150646.pdf [3/1/2024].Google Scholar
MoHLW (2015) International Pharmaceutical Regulatory Harmonization Strategy – Regulatory science initiative: www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/150827-01-01.pdf [3/1/2024].Google Scholar
MoH Malaysia (2013) Guidelines for stem cells and therapy – MOH/P/PAK/177.08(GU): www.moh.gov.my/images/gallery/Garispanduan/Stem_Cell/stem_cell_therapy.pdf.Google Scholar
MOJ (2021) Law of the People’s Republic of China on Basic Medical Health and Health Care and the Promotion of Health. 26 June: http://en.moj.gov.cn/2021-06/26/c_636455.htm [3/1/2024].Google Scholar
Mol, A. (2002) The Body Multiple: Ontology in Medical Practice. Durham: Duke University Press.CrossRefGoogle Scholar
Montgomery, C. M. (2012) Protocols and participatory democracy in a north–south product development partnership, Sociology, Health and Illness, 34(7): 1053–1069.10.1111/j.1467-9566.2011.01455.xCrossRefGoogle Scholar
MOPH (2017) Bureau of Drug Control: https://food.fda.moph.go.th/media.php?id=509382524116541440&name=No.367-(383).pdf [3/1/2024].Google Scholar
MRC (2012) A strategy for UK regenerative medicine: www.ukri.org/wp-content/uploads/2022/02/MRC-020222-AStrategyforUKRegenerativeMedicine.pdf [3/1/2024].Google Scholar
Munsie, M., and Pera, M. (2014) Regulatory loophole enables unproven autologous cell therapies to thrive in Australia, Stem Cells and Development, 23(S1): 34–38: www.liebertpub.com/doi/10.1089/scd.2014.0332 [3/1/2024].CrossRefGoogle ScholarPubMed
Murray, I. R., Chahla, J., Frank, R. M., Piuzzi, N. S., Mandelbaum, B. R., Dragoo, J. L., et al. (2020) Rogue stem cell clinics, Bone Joint Journal, 102-B(2): 148–154.Google ScholarPubMed
Nakatsuji, N. (2007) Irrational Japanese regulations hinder human embryonic stem cell research, Nature Reports, Stem Cells. 9 August: www.nature.com/stem-cells/2007/0708/070809/full/stemcells.2007.66.html [3/1/2024].CrossRefGoogle Scholar
Nakatstuji, N. (2015) サイエンスパレット。幹細胞学徒再生医療療[Saiensu-Paretto. Kansaibōgaku to Saisei Yiryō (Science Palette. Stem Cell Research and Regenerative Medicine)]. Kyoto: Maruzen.Google Scholar
Nature (2021) Portfolio. Regenerative Medicine: www.nature.com/subjects/regenerative-medicine [3/1/2024].Google Scholar
NEDO (2013) 再生・細胞医療技術および 製造インフラ最適化の研究開発: [Saisei saibō iryō gijutsu wo yo hi ゙ seizō infura saiteki-ka no kenkyū kaihatsu (Research and development of regenerative therapy, technology and the optimization of the manufacturing infrastructure)] www.nedo.go.jp/content/100873753.pdf [3/1/2024].Google Scholar
NEDO (2015) NEDO project activities: www.nedo.go.jp/english/introducing_pja.html [3/1/2024].Google Scholar
Nesta (2023) A healthy life: www.nesta.org.uk/healthy-life/?gclid=CjwKCAjw-b-kBhB-EiwA4fvKrCNxRcgrZvhU0Oq8aY6mATUZqAtgpoIZlkuD3Fhd9vZyLCT0WvpJwxoCOBwQAvD_BwE [3/1/2024].Google Scholar
Neuralstem (2014) Bioworld Asia: http://neuralstem.com/pharmaceuticals?id=206 [3/1/2024].Google Scholar
NHC (2019) 体细胞治疗临床研究和转化应用管理办法(试行)(征求意见稿)》[Tixibao zhiliao linchuang yanjiu he zhuanhua yingyong guanli banfa (shixing) (Management of clinical research and transformation applications for somatic cell therapy [Draft for Comment])]: www.nhc.gov.cn/wjw/yjzj/201903/01134dee9c5a4661a0b5351bd8a04822.shtml [8/2/2019].Google Scholar
NHMRC (2023) MRFF – 2023 Stem Cell Therapies Grant Opportunity (GO6227): www.nhmrc.gov.au/funding/find-funding/mrff-2023-stem-cell-therapies-grant-opportunity-go6227 [3/1/2024].Google Scholar
NHS (2020) Greener NHS campaign to tackle climate ‘health emergency’: www.england.nhs.uk/greenernhs/2020/01/greener-nhs-campaign-to-tackle-climate-health-emergency/ [3/1/2024].Google Scholar
NIH (2021) What are clinical trials and studies?: www.nia.nih.gov/health/what-are-clinical-trials-and-studies [3/1/2024].Google Scholar
Nikkei (2014) Japan aims to set global standards for regenerative medicine, Asian Review. 7 February: http://asia.nikkei.com/Business/Trends/Japan-aims-to-set-global-standards-for-regenerative-medicine [3/1/2024].Google Scholar
Nikkei (2016) Japanese companies ramping up regenerative products, Nikkei. 3 January: http://asia.nikkei.com/Business/Companies/Japanese-companies-ramping-up-regenerative-products [3/1/2024].Google Scholar
Niscell (2013) Niscell: www.niscell.com/stem-cell-therapy/ [5/1/2016].Google Scholar
Niscell (2024) Niscell – collaboration: www.niscell.org/collaboration [3/1/2024].Google Scholar
NIHBT (2011) Overview of current status of stem cell transplantation in Vietnam: www.wbmt.org/wp-content/uploads/2020/05/B1-1_Prof__TRI_T_NG_QUAN_TBG_-_E.pdf [3/1/2024].Google Scholar
NIHN (2022) Health Japan 21: www.nibiohn.go.jp/eiken/kenkounippon21/en/kenkounippon21/mokuhyou.html#Table01 [3/1/2024].Google Scholar
Nishikawa, S., Goldstein, R., and Nierras, C. R. (2008) The promise of human induced pluripotent stem cells for research and therapy, Nature Reviews Molecular Cell Biology, 9:725–729.CrossRefGoogle ScholarPubMed
NMPA (2017) 《细胞治疗产品研究与评价技术指导原则》（试行）[Xibao zhiliao chanpin yanjiu yu pinjia jishu zhidao yuance <shixing> (Guiding principles for the research and evaluation of cellular therapy products [trial])] 18 December: www.nmpa.gov.cn/WS04/CL2138/300457.html [8/2/2019].+(Guiding+principles+for+the+research+and+evaluation+of+cellular+therapy+products+[trial])]+18+December:+www.nmpa.gov.cn/WS04/CL2138/300457.html+[8/2/2019].>Google Scholar
Nomura, I. (2021) PMDA wa neicha-shi ni kusshita no ka? (in Japanese) (Did PMDA finally give in to Nature?), Nikkei Medikaru. 6 October: https://medical.nikkeibp.co.jp/leaf/mem/pub/eye/202110/572229.html [3/1/2024].Google Scholar
Normile, D. (2015) RIKEN announces penalties related to stem cell fiasco. 10 February: www.sciencemag.org/news/2015/02/riken-announces-penalties-related-stem-cell-fiasco [3/1/2024].CrossRefGoogle Scholar
Normile, D. (2017) Cutting-edge stem cell therapy proves safe, but will it ever be effective?, Science. 15 March: www.sciencemag.org/news/2017/03/cutting-edge-stem-cell-therapy-proves-safe-will-it-ever-be-effective [3/1/2024].Google Scholar
Nussbaum, M. (1986) The Fragility of Goodness. Cambridge: Cambridge University Press.Google Scholar
Nwobike, J. (2006) Pharmaceutical corporations and access to drugs in developing countries, SUR – International Journal on Human Rights, 4: 127–143.Google Scholar
OECD (2002) Regulatory policies in OECD countries: From interventionism to regulatory governance: https://doi.org/10.1787/9789264177437-en [3/1/2024].CrossRefGoogle Scholar
Oh, I. H. (2012) Regulatory issues in stem cell therapeutics in Korea: Efficacy or efficiency?, Korean Journal of Hematology, 47: 87–89.CrossRefGoogle ScholarPubMed
Okura, H., and Matsuyama, Y. (2017) History of development and regulations for regenerative medicines in Japan, Journal for Stem Cell Research and Therapy, 7(1): www.longdom.org/open-access/history-of-development-and-regulations-for-regenerative-medicines-in-japan-2157-7633-1000372.pdf [3/1/2024].CrossRefGoogle Scholar
Olson (2015) Fringe medical practices in Thailand: www.thailawforum.com/laws/medical-practices-thailand-stem-cell-cloning-cancer-sex-change.pdf [3/1/2024].Google Scholar
Page, S. E. (2006) Path dependence, Quarterly Journal of Political Science, 1(1): 87–115: https://web.archive.org/web/20160629130434/http://dev.wcfia.harvard.edu/sites/default/files/Page2006.pdf [3/1/2024].CrossRefGoogle Scholar
Pandya, S. (2008) Stem cell transplantation in India: Tall claims, questionable ethics, Indian Journal of Medical Ethics, 5(1): 15–17.Google ScholarPubMed
Parekkadan, B., and Milwid, J. M. (2010) Mesenchymal stem cells as therapeutics, Annual Review of Biomedical Engineering, A15(12): 87–117.CrossRefGoogle Scholar
Patra, P. K., and Sleeboom-Faulkner, M. (2009) Bionetworking: Experimental stem cell therapy and patient recruitment in India, Anthropology & Medicine, 16(2): 147–163.CrossRefGoogle ScholarPubMed
Patra, P. K., and Sleeboom-Faulkner, M. (2017) Bionetworking and strategic linking between India and Japan: How clinical stem cell intervention continues despite new regulatory guidelines, East Asia Journal for Science and Technology Studies, EASTS, 11(3): 353–372.Google Scholar
PATR Life (2022) PATR Life Clinic @patrlife Beauty, cosmetic & personal care: www.facebook.com/patrlife/ [3/1/2024].Google Scholar
People’s Daily (2005) China allows first stem cell injection into clinical test. 2 February: http://english.peopledaily.com.cn/200502/02/eng20050202_172653.html [6/12/2017].Google Scholar
Pérez Velasco, R., Chaikledkaew, U., Myint, C. Y., Khampang, R., Tantivess, S.,et al. (2013) Advanced health biotechnologies in Thailand: Redefining policy directions, Journal of Translational Medicine, 11(1): www.translational-medicine.com/content/11/1/1 [3/1/2024].Google Scholar
Perrone, M. (2021) US stem cell clinics boomed while FDA paused crackdown, Science – PBS. 30 September: www.pbs.org/newshour/science/us-stem-cell-clinics-boomed-while-fda-paused-crackdown [3/1/2024].Google Scholar
Petersen, A., Seear, K., and Munsie, M. (2013) Therapeutic journeys: The hopeful travails of stem cell tourists, Sociology of Health and Illness, 36(5): 670–685.10.1111/1467-9566.12092CrossRefGoogle ScholarPubMed
Petersen, A., Munsie, M., Tanner, C., MacGregor, C., and Brophy, J. (2017) Stem Cell Tourism and the Political Economy of Hope. Basingstoke: Palgrave MacMillan.10.1057/978-1-137-47043-0CrossRefGoogle Scholar
Petryna, A. (2007) Clinical trials offshored: On private sector science and public health, BioSocieties, 2(1): 21–40.10.1017/S1745855207005030CrossRefGoogle Scholar
Petryna, A. (2009) When Experiments Travel. Princeton: Princeton University Press.10.1515/9781400830824CrossRefGoogle Scholar
PFSC (2021) Patients For Stem Cells: https://patientsforstemcells.org/.Google Scholar
Pham, P. (2016) Current status of stem cell transplantation in Vietnam, Biomedical Research and Therapy, 3(4): 578-587: www.bmrat.org/index.php/BMRAT/article/view/89 [3/1/2024].Google Scholar
PharmaBiz (2012) Stempeutics to look for tie-ups with global medical device majors for ‘Stempeutron’. PharmaBiz. 5 April.Google Scholar
Philippidis, A. (2014) Japan moves to regain prominence in biotech, Gen. 28 January: www.genengnews.com/insight-and-intelligence/japan-moves-to-regain-prominence-in-biotech/77900022/ [3/1/2024].Google Scholar
Philippidis, A. (2018) 10 takeover targets of 2018, Gen. 26 February: www.genengnews.com/a-lists/10-takeover-targets-of-2018/ [3/1/2024].Google Scholar
Pigeau, G. M., Csaszar, E., and Dulgar-Tulloch, A. (2018) Commercial scale manufacturing of allogeneic cell therapy, Frontier Medicine, 5: 233: www.frontiersin.org/articles/10.3389/fmed.2018.00233/full [3/1/2024].CrossRefGoogle ScholarPubMed
Pittenger, M. F., Discher, D. E., Péault, B. M., et al. (2019) Mesenchymal stem cell perspective: Cell biology to clinical progress, Regenerative Medicine, 4: 22.Google ScholarPubMed
Pluristem (2016) Pluristem Therapeutics Inc: www.pluristem.com/wp-content/uploads/2016/05/Japan_Approves_Cells_isa.pdf [8/2/2019].Google Scholar
PMDA (2015) PMDA Strategic Plan 2015: www.pmda.go.jp/english/int-activities/outline/0017.html [3/1/2024].Google Scholar
PMDA (2016) International Regulatory Forum of Human Cell Therapy and Gene Therapy Products: www.pmda.go.jp/files/000211283.pdf [3/1/2024].Google Scholar
PMDA (2017) The Fourth Thailand-Japan Symposium: www.pmda.go.jp/english/symposia/0099.html [3/1/2024].Google Scholar
PMDA (2017) Regulation of regenerative medicine in Japan. Presentation by Yoshiaki Murayama: www.pmda.go.jp/files/000219466.pdf [3/1/2024].Google Scholar
PMDA (2018) Report of the PMDA-ATC MRCT Seminar 2018: www.pmda.go.jp/english/symposia/0125.html [3/1/2024].Google Scholar
PMDA (2021) GCTP適合性調査 [GCTP tekigō-sei chōsa (GCTP Compatibility Survey)]: www.pmda.go.jp/review-services/gmp-qms-gctp/gctp/0002.html [3/1/2024].Google Scholar
PMDA (undated) Review reports regenerative medicine products: www.pmda.go.jp/english/review-services/reviews/approved-information/0004.html [3/1/2024].Google Scholar
Polak, T. B., Cucchi, D. G., Darrow, J. J., et al. (2022) Incremental benefits of novel pharmaceuticals in the UK: A cross-sectional analysis of NICE technology appraisals from 2010 to 2020, BMJ [British Medical Journal] Open, 12: e058279: https://bmjopen.bmj.com/content/bmjopen/12/4/e058279.full.pdf [3/1/2024].CrossRefGoogle Scholar
PRNewswire (2014) Cell line development market by product (equipment, media and reagents): https://bit.ly/41IwrHI [3/1/2024].Google Scholar
Pyre, S. (2012) Dr. Cornelis Kleinbloesem & Cells4health: Scam or stem cell pioneers?, Stem Cell Therapy Review Journal. 8 April: https://stemcelltherapyreviewjournal.com/cells4health-dr-cornelis-kleinbloesem-scam-or-stem-cell-pioneers/ [5/1/2021].Google Scholar
Qiu, X., Feng, J. R., Chen, L. P., Liu, S., Zhang, M., et al. (2017) Efficacy and safety of autologous hematopoietic stem cell therapy for refractory Crohn’s disease: A systematic review and meta-analysis, Medicine, 96(26), e7381: https://doi.org/10.1097/MD.0000000000007381 [3/1/2024].CrossRefGoogle ScholarPubMed
QLifePro (2018) 再生医療の規制調和目指す-アジア初の国際会議開催 [Saisei iryō no kisei chōwa mezasu – ajia-hatsu no kokusai kaigi kaisai (Aiming to Harmonise Regulation for Regenerative Medicine – Inaugural International Conference in Asia)]: www.qlifepro.com/news/20180416/regulated-harmony-of-regenerative-medicine-aim.html [3/1/2024].Google Scholar
Queen Mary University of London (2018) Stem cell transplants to be used in treating Crohn’s disease: www.qmul.ac.uk/media/news/2018/smd/stem-cell-transplants-to-be-used-in-treating-crohns-disease.html [3/1/2024].Google Scholar
Rabeharisoa, V. (2006) From representation to mediation: The shaping of collective mobilization on muscular dystrophy in France. Social Science & Medicine, 62: 564–576.10.1016/j.socscimed.2005.06.036CrossRefGoogle ScholarPubMed
Rabeharisoa, V., Moreira, T., and Akrich, M. (2014) Introduction to evidence-based activism: Patients’, users’ and activists’ groups in knowledge society, BioSocieties, 9(2): 111–128.CrossRefGoogle Scholar
Raffaelli, R. (2018) The principle of subsidiarity, European Parliament 2017, Fact Sheets on the European Union: www.europarl.europa.eu/ftu/pdf/en/FTU_1.2.2.pdf [3/1/2024].Google Scholar
Rayment, E. A., and Williams, D. J. (2010) Concise review: Mind the gap: Challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation, Stem Cells, 28(5): 996–1004.10.1002/stem.416CrossRefGoogle Scholar
Regeneus (2014) Release: https://regeneus.com.au/wp-content/uploads/141126-rgs-new-japanese-laws-take-effect.pdf [3/1/2024].Google Scholar
Remudy (2021) Remudy: www.remudy.jp/ [3/1/2024].Google Scholar
RePricel (2013) Press Release. 28 May: https://bit.ly/4azZVeS [3/1/2024].Google Scholar
Research and Markets (2020) Regenerative medicine markets analysis and forecast, September: www.researchandmarkets.com/reports/5144903/global-regenerative-medicine-market-analysis-and [3/1/2024].Google Scholar
Resnik, D. B., Shamoo, A. E., and Krimsky, S. (2006) Fraudulent human embryonic stem cell research in South Korea: Lessons learned, Accountability in Research, 13(1), 101–109.10.1080/08989620600634193CrossRefGoogle ScholarPubMed
Richer, S. (2011) Governor Rick Perry puts ‘off-label’ medical therapy on stage, Forbes. 8 August: www.forbes.com/sites/wlf/2011/08/08/governor-rick-perry-puts-off-label-medical-therapy-on-stage/ [3/1/2024].Google Scholar
Robinson, P. G., Murray, I. R., West, C. C., et al. (2019) Reporting of mesenchymal stem cell preparation protocols and composition: A systematic review of the clinical orthopaedic literature, The American Journal of Sports Medicine, 47(4): 991–1000.10.1177/0363546518758667CrossRefGoogle ScholarPubMed
Rose, N., and Miller, P. (1992) Political power beyond the State: Problematics of government, The British Journal of Sociology, 43(2), 173–205.10.2307/591464CrossRefGoogle Scholar
Rosemann, A. (2013) Medical innovation and national experimental pluralism, BioSocieties, 8(1): 58–74.CrossRefGoogle Scholar
Rosemann, A (2014a) Why regenerative stem cell medicine progresses slower than expected, Journal of Cellular Biochemistry 115: 2073–2076.10.1002/jcb.24894CrossRefGoogle ScholarPubMed
Rosemann, A. (2014b) Standardization as situation-specific achievement: Regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine, Social Science and Medicine, 122: 72–80.CrossRefGoogle ScholarPubMed
Rosemann, A., and Sleeboom-Faulkner, M. (2016) New regulation for clinical stem cell research in China: expected impact and challenges for implementation, Regenerative Medicine, 11(1): 5–9.CrossRefGoogle Scholar
Ratcliffe, E., Glen, K. E., Naing, M. W., and Williams, D. J. (2013) Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: Case studies, British Medical Bulletin, 108(1): 73–94.CrossRefGoogle ScholarPubMed
Saeedi, P., Halabian, R., Fooladi, A. A. I. (2019) A revealing review of mesenchymal stem cells therapy, clinical perspectives and modification strategies, Stem Cell Investigations, 6: 34: www.ncbi.nlm.nih.gov/pmc/articles/PMC6789202/ [3/1/2024].CrossRefGoogle ScholarPubMed
Saengpassa, C., and Sarnsamak, P. (2012) Thai successes in stem-cell research have come despite a lack of funding, The Nation. 22 October:www.nationmultimedia.com/national/Show-scientists-the-road-30192788.html [3/3/2015].Google Scholar
Sakai, M. (2014) Patients’ commitment in a clinical trial program: Examining Japanese regenerative medicine for spinal cord injuries, Core Ethics 10: 97–108.Google Scholar
Salter, B. (2007) State strategies and speculative innovation in regenerative medicine: The global politics of uncertain future, GBRG Working Papers, no. 20. July.Google Scholar
Salter, B. (2009) State strategies and the geopolitics of the global knowledge economy: China, India and the case of regenerative medicine, Geopolitics, 14(1): 47–78.CrossRefGoogle Scholar
Salter, B., and Qiu, R. (2009) Bioethical governance and basic stem cell science: China and the global biomedicine economy, Science and Public Policy 36(1): 47–59.10.3152/030234209X410381CrossRefGoogle Scholar
Salter, B, Zhou, Y., and Datta, S. (2015) Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science, Social Science & Medicine, 131: 156–163.10.1016/j.socscimed.2015.03.015CrossRefGoogle ScholarPubMed
Scanian, E. (2015) Trial to test stem cells for knee osteoarthritis: www.eurostemcell.org/trial-test-stem-cells-knee-osteoarthritis [3/1/2024].Google Scholar
SCETRA 2016. Message from the president: www.scetra.or.jp/en/union/ [3/1/2024].Google Scholar
Sengoku, S., Mitsuya, S., and Yoshimi, Y. (2015) Regulatory review: Japan’s regulatory framework: Seeking to provide impetus to the commercialisation of regenerative medicine products, Cell & Gene Therapy Insights: file:///Users/ms284/Downloads/Sengoku1.pdf [3/1/2024].CrossRefGoogle Scholar
Seyhan, A. A. (2019) Lost in translation: The valley of death across preclinical and clinical divide – identification of problems and overcoming obstacles, Translational Medicine Communications, 4, 18: https://doi.org/10.1186/s41231–019-0050-7 [3/1/2024].CrossRefGoogle Scholar
Sheldon, T. 2007. The Netherlands ban private stem cell therapy, British Medical Journal, 334: 12.CrossRefGoogle Scholar
Shakespeare, T. (1993) Disabled people’s self-organization: A new social movement?, Disability and Society, 8(3): 249–264.CrossRefGoogle Scholar
Sharma, A., Gokulchandran, N., Sane, H., and Badhe, P. (2014) Stem Cell Therapy in Neurological Disorders. Mumbai: Surekha Press.Google Scholar
Sharma, A., Gokulchandran, N., Sane, H., Badhe, P., and Paranjape, A. (2016) Current global trends in regulations for stem cell therapy and the way ahead for India, Indian Journal of Stem Cell Therapy, 2(1): 5–15.Google Scholar
Shizhentang (2014) Shizhentang (in Chinese): www.ganxibaowang.com/ [12/5/2017].Google Scholar
Shrum, W., Joel, G., and Ivan, C. (2007) Structures of Scientific Collaboration. Baskerville: MIT Press.CrossRefGoogle Scholar
Shrum, W. (2010) Collaborationism. In Parker, J., Vermeulen, N. and Penders, B. (eds.) Collaboration in the New Life Sciences. Farnham; Burlington: Ashgate, 247–258.Google Scholar
Siebers, T. (2011) Disability Theory. Ann Arbor: University of Michigan Press.Google Scholar
Singh, M. (2018) India Proposes to Regulate Stem Cells as Drugs; to require clinical trials, licenses: www.indiaspend.com/india-proposes-to-regulate-stem-cells-as-drugs-to-require-clinical-trials-licenses-80799/ [3/1/2024].Google Scholar
Sinostemcells (2015) Sinostemcells: www.sinostemcells.com// [3/1/2024].Google Scholar
Sipp, D. (2009) The rocky road to regulation, Nature Reports Stem Cells. 23 September.10.1038/stemcells.2009.125CrossRefGoogle Scholar
Sipp, D. (2011) Blog: http://sctmonitor.blogspot.co.uk/2011/01/beike-biotech-under-new-ownership.html [3/1/2024].Google Scholar
Sipp, D. (2012) Pay-to-participate funding schemes in human cell and tissue clinical studies, Regenerative Medicine, 7(6 Suppl.): 105–111.CrossRefGoogle Scholar
Sipp, D. (2015) Conditional approval: Japan lowers the bar for regenerative medicine products, Cell Stem Cell, 16(4), 353–356.10.1016/j.stem.2015.03.013CrossRefGoogle ScholarPubMed
Sipp, D., and Turner, L.G. (2012) US regulation of stem cells as medical products, Science, 338(6112): 1296–1297.10.1126/science.1229918CrossRefGoogle ScholarPubMed
Sipp, D, Caulfield, T, Kaye, J, Barfoot, J, Blackburn, C, Chan, S., et al. (2017) Marketing of unproven stem cell–based interventions: A call to action, Science Translational Medicine, 9(397): 426.CrossRefGoogle Scholar
Sipp, D., and Okano, H. (2018) Japan strengthens regenerative medicine oversight, Cell Stem Cell, 22(2): 153–156.10.1016/j.stem.2018.01.001CrossRefGoogle ScholarPubMed
Sipp, D., Robey, P. G., and Turner, L. (2018) Clear up this stem-cell mess, Nature, 561(7724): 455–457.CrossRefGoogle ScholarPubMed
Sipp, D., and Sleeboom-Faulkner, M. (2019) Downgrading the regulation of regenerative medicine, Science, 365: 644–646.CrossRefGoogle ScholarPubMed
Sleeboom-Faulkner, M. (2010a) Boundary making and ‘good’ stem cell research (SCR) in mainland China: Including bioethics, excluding debate, East Asian Science, Technology and Society: An International Journal, 4: 31–51.10.1215/s12280-010-9114-5CrossRefGoogle Scholar
Sleeboom-Faulkner, M (2010b) National risk signatures and human embryonic stem cell research in Mainland China, Health, Risk and Society, 12(5):491–511.10.1080/13698575.2010.509491CrossRefGoogle Scholar
Sleeboom-Faulkner, M. (2011a) Regulating cell lives in Japan: Avoiding scandal & sticking to nature, New Genetics and Society, 3: 227–240.10.1080/14636778.2011.598052CrossRefGoogle Scholar
Sleeboom-Faulkner, M. (2011b) Stem cell research in Asia: Looking beyond formal regulatory exteriors – Introduction, New Genetics and Society, 2: 133–137.Google Scholar
Sleeboom-Faulkner, M. (2013) Latent science collaboration: Strategic cultures of bioethical capacity building in Mainland China’s stem cell world, Biosocieties, 8: 7–24.CrossRefGoogle Scholar
Sleeboom-Faulkner, M. (2014) Global Morality and Life Science Practices in Asia: Assemblages of Life. Basingstoke; New York: Palgrave MacMillan.10.1057/9781137317407CrossRefGoogle Scholar
Sleeboom-Faulkner, M. (2016) The large grey area between ‘bona fide’ and ‘rogue’ stem cell interventions: Ethical acceptability and the need to include local variability, Technological Forecasting and Social Change, 109: 76–86.CrossRefGoogle Scholar
Sleeboom-Faulkner, M. (2019) Regulatory brokerage: Competitive advantage and regulation in the field of regenerative medicine, Social Studies of Science, 49: 355–380.10.1177/0306312719850628CrossRefGoogle ScholarPubMed
Sleeboom-Faulkner, M., and Patra, P. K. (2011) Experimental stem cell therapy: Biohierarchies and bionetworking in Japan and India, Social Studies of Science, 41(5): 696–707.10.1177/0306312711409792CrossRefGoogle ScholarPubMed
Sleeboom-Faulkner, M., Chekar, C. K., Faulkner, A., et al. (2016) Comparing national home-keeping and the regulation of translational stem cell applications: An international perspective, Social Science and Medicine, 153, 240–249.10.1016/j.socscimed.2016.01.047CrossRefGoogle ScholarPubMed
Sleeboom-Faulkner, M., Chen, H., and Rosemann, A. (2018) Regulatory capacity building and the governance of clinical stem cell research in China, Science and Public Policy, 45(3): 416–427.CrossRefGoogle Scholar
Slingby, B. T, Nagao, N., and Akabayashi, A. (2004) Administrative legislation in Japan: Guidelines on scientific and ethical standards, Cambridge Quarterly of Healthcare Ethics, 13: 245–253.Google Scholar
Smith, R. (2021) Time to assume that health research is fraudulent until proven otherwise?, BMJ [British Medical Journal] Opinion: https://blogs.bmj.com/bmj/2021/07/05/time-to-assume-that-health-research-is-fraudulent-until-proved-otherwise/ [3/1/2024].Google Scholar
Soares, F., et al. (2014) Investigating the feasibility of scale up and automation of human induced pluripotent stem cells cultured in aggregates in feeder free conditions, Journal of Biotechnology, 173: 53–58.10.1016/j.jbiotec.2013.12.009CrossRefGoogle ScholarPubMed
Sohn, J. Y. (2018) Nature Cell’s stem cell treatment for Alzheimer’s approved in Japan, Korea Herald. 20 March: www.koreaherald.com/view.php?ud=20180320000783 [3/1/2024].Google Scholar
Sohn, R. L., and Gussoni, E. (2004) Stem cell therapy for muscular dystrophy, Expert Opinion on Biological Therapy, 4(1):1–9.CrossRefGoogle ScholarPubMed
Song, P. (2010) Biotech pilgrims and the transnational quest for stem cell cures, Medical Anthropology, 29(4): 384–402.CrossRefGoogle ScholarPubMed
Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: Problematizing ethical regulation, New Genetics and Society, 30(2): 141–153.10.1080/14636778.2011.574375CrossRefGoogle Scholar
Sousa, C. A. (2013) Political violence, collective functioning and health: A review of the literature, Medical Conflict and Survival, 29(3): 169–197.CrossRefGoogle Scholar
Srinivasan, S. (2006) Rogue research in the guise of stem cell therapy. Infochange Public Health: http://infochangeindia.org/public-health/features/rogue-research-in-the-guise-of-stem-cell-therapy.html [3/2/2017].Google Scholar
Stemcellconsortium (2023) Stemcellconsortium: https://stemcellconsortium.org/ [3/1/2024].Google Scholar
Stem Cell Pioneers (2011) ACMS and AABB announce alliance: https://stemcellpioneers.com/threads/icms-and-aabb-announce-alliance.5092/ [3/1/2024].Google Scholar
StemcellMalaysia (2021) Stem cell therapy: www.cellmalaysia.com/ [3/1/2024].Google Scholar
StemlifeMalaysia (2022) StemLife: www.stemlife.com/en/malaysia/corporate_information/history.html [3/1/2024].Google Scholar
Stempeutics (2013) Clinical trials: www.stempeutics.com/clinical_trials.html [8/12/2015].Google Scholar
Stempeutics (2015) Products: Current focus of Stempeutics: www.stempeutics.com/products.html [8/12/ 2015].Google Scholar
Stengers, I. (2018) Another Science Is Possible: A Manifesto for Slow Science. Cambridge: Polity Press.Google Scholar
Suda, M. (2015) 捏造の科学者ースタップ細胞事件 [Netsuzō no Kagakusha – Sutappu Saibō Jiken (Fabricating Scientists: The STAP incident]. Tokyo: Bungei Shunjukan.Google Scholar
Sui, S., and Sleeboom-Faulkner, M. (2010) Choosing offspring: Case studies of prenatal genetic testing for thalassemia and the reproduction of a ‘saviour sibling’ in China, Culture, Health and Sexuality, 12(2): 167–175.CrossRefGoogle Scholar
Sui, S., and Sleeboom-Faulkner, M. (2015) Governance of stem cell research and its clinical translation in China, EASTS, 9: 1–16.CrossRefGoogle Scholar
Sunder Rajan, K (2006) Biocapital: The Constitution of Postgenomic Life. Durham: Duke University Press.Google Scholar
Stiglitz, J. (2002) Globalization and Its Discontents. London; New York: Penguin Books.Google Scholar
Takahashi, K., and Yamanaka, S. (2006) Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors, Cell, 126: 663–676.10.1016/j.cell.2006.07.024CrossRefGoogle ScholarPubMed
Takahashi, K., Tanabe, K., Ohnuki, M., Narita, M., Ichisaka, T., et al. (2007) Induction of pluripotent stem cells from adult human fibroblasts by defined factors, Cell, 131: 861–872.10.1016/j.cell.2007.11.019CrossRefGoogle ScholarPubMed
Takenaka, T. (2005) Technology licensing and university research in Japan, International Journal of Intellectual Property, 1: 27–36.Google Scholar
Tam, F. (2011) Medicine’s wild east, China South Morning Post. 17 May: www.scmp.com/article/967932/medicines-wild-east [3/1/2024].Google Scholar
Terumo, (2015) News room, press release. 18 September: www.terumo.com/pressrelease/detail/20150918/307/index.html [23/4/2019].Google Scholar
TFDA (2017) ASEAN Consultative Committeefor Standards and Quality – Pharmaceutical Product Working Group: www.fda.gov.tw/tc/includes/GetFile.ashx?mID=133&id=66509 [3/1/2024].Google Scholar
TGA (Therapeutic Goods Administration) (2011) Therapeutic goods (things that are not biologicals) determination no. 1: www.legislation.gov.au/Details/F2011L00894 [3/1/2024].Google Scholar
TGA (Therapeutic Goods Administration) (2015) Products regulated as biologicals: www.tga.gov.au/what-regulated-biological [3/1/2024].Google Scholar
TGA (Therapeutic Goods Administration) (2019) TGA strengthens regulation of stem cell treatments: https://bit.ly/3S3r0zN [3/1/2024].Google Scholar
Thailand Medical News (2019) Certain clinics in Thailand offering fraudulent stem cell treatment: www.thailandmedical.news/news/certain-clinics-in-thailand-offering-fraudulent-stem-cell-treatments [3/1/2024]Google Scholar
Thanawin (2013) Thanawin holding: http://thanawinholding.com/Thanawin_Holding/News%26Events.html) [3/1/2024].Google Scholar
Thomas, R., Chandra, A., Hourd, P., and Williams, D. (2008) Cell culture automation and quality engineering: A necessary partnership to develop optimised manufacturing processes for cell-based therapies, Journal of the Association for Laboratory Automation, 13(3):152–158.10.1016/j.jala.2007.12.003CrossRefGoogle Scholar
Thomas, P. T., Rajaram, P., and Nalinia, A. (2014) Family care giving in Duchenne Muscular Dystrophy: Is there a gender difference?, IOSR Journal of Nursing and Health Science (IOSR-JNHS), 3(6): 17–22.10.9790/1959-03631722CrossRefGoogle Scholar
Thompson, C. (2013) Good Science: The Ethical Choreography of Stem Cell Research. Cambridge, MA: MIT Press.CrossRefGoogle Scholar
Thomson, A. J., Itskovitz-Eldor, J., Shapiro, S. S., Waknitz, M. A., Swiergiel, J. J., Marshall, V. S., and Jones, J. M. (1998) Embryonic stem cell lines derived from human blastocysts, Science, 282(5391): 1145–1147.CrossRefGoogle ScholarPubMed
Thomson Reuters (2015) Medicinal product regulation and product liability in Vietnam: Overview: http://us.practicallaw.com/6-518-6504?q=&qp=&qo=&qe= [3/1/2024].Google Scholar
Timmermans, S., and Epstein, S. (2010) A world of standards but not a standard world: Toward a sociology of standards and standardization, Annual Review of Sociology, 36, 69–89.10.1146/annurev.soc.012809.102629CrossRefGoogle Scholar
Timmermans, S., and Tavory, I. (2012) Theory construction in qualitative research: From grounded theory to abductive analysis, Sociological Theory, 30: 167–186.10.1177/0735275112457914CrossRefGoogle Scholar
Tiwari, S. S., and Desai, P. N. (2018) Unproven stem cell therapies in India: Regulatory challenges and proposed paths forward, Cell Stem Cell, 23: 649–652.10.1016/j.stem.2018.10.007CrossRefGoogle ScholarPubMed
Tiwari, S. S., and Raman, S. (2014) Governing stem cell therapy in India: Regulatory vacuum or jurisdictional ambiguity?, New Genetics and Society, 33(4): 413–433.CrossRefGoogle ScholarPubMed
TMC (Thai Medical Council) (2009) Rules on the observance on medical ethics regarding stem cell transplantation for therapeutic treatment B. E. 2552 [in Thai]: www.tmc.or.th/download/stemcell.pdf [3/1/2024].Google Scholar
Tobita, M., Konomi, K., Torashima, Y., Kimura, K., Taoka, M., and Kaminota, M. (2016) Commentary on Japan’s challenges of translational regenerative medicine: Act on the safety of regenerative medicine, Regenerative Therapy, 4: 78–81.CrossRefGoogle Scholar
Tsai, T.-H., Ling, T.-Y., Lee, C.-H. (2020) Adoption of regulations for cell therapy development: Linkage between Taiwan and Japan, Clinical Translation Science, 13: 1045–1047: https://pubmed.ncbi.nlm.nih.gov/32407601/ [3/1/2024].10.1111/cts.12813CrossRefGoogle ScholarPubMed
Tsuyuki, K., Yano, K., Watanabe, N., Aruga, A., and Yamato, M. (2016) Compassionate use of drugs and medical devices in the United States, the European Union and Japan, Regenerative Therapy, 4: 18–26.10.1016/j.reth.2015.11.002CrossRefGoogle ScholarPubMed
Turner, L. G. (2017) ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies, Regenerative Medicine, 12(6): 705–719.CrossRefGoogle ScholarPubMed
Turner, L. G. (2021) The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions, Cell Stem Cell, 28(11): 1891–1895.CrossRefGoogle ScholarPubMed
Turner, L. G., and Knoepfler, P. (2016) Selling stem cells in the USA: Assessing the direct-to-consumer industry, Cell Stem Cell, 19(2): 154–157.10.1016/j.stem.2016.06.007CrossRefGoogle ScholarPubMed
UKRI (2020) UK and Japan award eight regenerative medicine projects: www.ukri.org/news/uk-and-japan-award-eight-regenerative-medicine-projects/ [3/1/2024].Google Scholar
UKRI (2022) The role of pro-inflammatory mesenchymal stem cells in rheumatoid arthritis: https://gtr.ukri.org/projects?ref=MR%2FK008862%2F1 [3/1/2024].Google Scholar
Umemura, M. (2011) The Japanese Pharmaceutical Industry. London: Routledge.10.4324/9780203831281CrossRefGoogle Scholar
Umemura, M. (2015) Positioning Asia in the Japanese regenerative medicine industry: The case of China and India, Working Paper. 31 May: www.kcl.ac.uk/sspp/departments/…/research/…/Working-Paper-50-(2015).pdf [14/3/2020].Google Scholar
UN (2016) The United Nationals Secretary-General’s High-Level Panel on Access to Medicines Report: www.unsgaccessmeds.org/final-report [3/1/2024].Google Scholar
Union Stem Cell (2014) 协和孕妇大学 [XieheYunfu Daxue (University for Pregnant Women)]: www.chinastemcell.com/about-xiehe/xiehe-gravida-college.html [2/1/2017].Google Scholar
US-FDA (2007) 21 CFR Part 1271: Human cells, tissues, and cellular and tissue-based products: www.Accessdata.Fda.Gov/Scripts/Cdrh/Cfdocs/Cfcfr/Cfrsearch.Cfm?Cfrpart=1271&Showfr=1 [3/1/2024].Google Scholar
US-FDA (2012) 21 CFR 312.8: Charging for investigational drugs under an IND: www.govinfo.gov/app/details/CFR-2012-title21-vol5/CFR-2012-title21-vol5-sec312-8 [3/1/2024].Google Scholar
US-FDA (2014a) Investigational new drug applications: www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm [3/1/2024].Google Scholar
US-FDA (2014b) Expedited programs for serious conditions – drugs and biologics: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf [3/1/2024].Google Scholar
US-FDA (2014c) Fast track, breakthrough therapy, accelerated approval and priority review: www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm [6/5/2023].Google Scholar
US-FDA (2017a) Same surgical procedure exception under 21 CFR 1271.15(b): Questions and answers regarding the scope of the exception. 2017: https://bit.ly/47rGHoR [3/1/2024].Google Scholar
US-FDA (2017b) FDA announces comprehensive regenerative medicine policy framework. 19 November: www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework [3/1/2024].Google Scholar
US-FDA (2019) Statement from FDA Commissioner Scott Gottlieb, MD and Peter Marks, MD, PhD. FDA press announcement, January: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629493.htm [3/1/2024].Google Scholar
VietnamNet (2013) Growing stem cells – a new profitable business in Vietnam: https://vietnamnet.vn/en/growing-stem-cells-a-new-profitable-business-in-vietnam-E71113.html [3/1/2024].Google Scholar
Villa Medica (2020) EV Villa Medica, innovative regenerative medicine: https://ewvillamedica.com/ [3/1/2024].Google Scholar
Vogel, S. K. (1996) Freer Markets, More Rules. Regulatory Reform in Advanced Industrial Countries. Ithaca; London: Cornel University Press.Google Scholar
Von Tigerstrom, B. (2015) Revising the regulation of stem cell-based therapies: Critical assessment of potential models, Food Drug Law Journal, 70(2): 315–337.Google ScholarPubMed
Wade, R. (2003) What strategies are viable for developing countries today? The World Trade Organisation and the shrinking of ‘development space’, Review of International Political Economy, 10(4): 621–644.10.1080/09692290310001601902CrossRefGoogle Scholar
Wahlberg, A., Rehmann-Sutter, C., Sleeboom-Faulkner, M., Lu, G., Döring, O., and Cong, Y. (2013) From global bioethics to ethical governance of biomedical research collaborations, Social Science & Medicine, 98: 293–300.CrossRefGoogle ScholarPubMed
Walk Again (2015) HAL® Therapy – current scientific studies: http://walk-again.com/research/ [3/1/2024].Google Scholar
Washington State (2022) AG Ferguson wins $500,000 for individuals impacted by US Stemology’s unproven claims that its stem cell injections could treat COVID-19 and other medical conditions. 9 June: www.atg.wa.gov/news/news-releases/ag-ferguson-wins-500000-individuals-impacted-us-stemology-s-unproven-claims-its [3/1/2024].Google Scholar
Waters, T., and Waters, D. (eds.) (2015) Weber’s Rationalism and Modern Society. Basingstoke; New York: Palgrave MacMillan.10.1057/9781137365866CrossRefGoogle Scholar
Whatclinic (2022) Whatclinic Malaysia: www.whatclinic.com/oncology/malaysia [3/1/2024].Google Scholar
Wang, J. (2011) 国家干细胞研究指导协调委员会成立 [Guojia ganxibao yanjiu zhidao bandiao weiyuanhui chengli (Establishing the National Stem Cell Leadership and Coordination Committee)]. 21 Octobter: http://news.sciencenet.cn/htmlnews/2011/10/254182.shtm [3/1/2024].Google Scholar
Wangkiat, P. (2015) Ministry eyes stem cell therapy adverts, Bangkok Post. 23 February: www.bangkokpost.com/thailand/general/480996/ministry-eyes-stem-cell-therapy-adverts [3/1/2024].Google Scholar
Watanabe, S., Kodama, S., and Hanabusa, H. (2018) Longevity and elderly care: Lessons from Japan, Global Health Journal, 2(4): 5–10.CrossRefGoogle Scholar
Webster, A. (ed.) (2013) The Global Dynamics of Regenerative Medicine: A Social Science Critique. Basingstoke; New York: Palgrave MacMillan.CrossRefGoogle Scholar
WHO (2012) Pharmaceutical financing strategies (MSD-3), chapter 11: http://apps.who.int/medicinedocs/documents/s19587en/s19587en.pdf [3/1/2024].Google Scholar
WHO (2017) World Bank and WHO: Half the world lacks access to essential health services, 100 million still pushed into extreme poverty because of health expenses: www.who.int/news/item/13-12-2017-world-bank-and-who-half-the-world-lacks-access-to-essential-health-services-100-million-still-pushed-into-extreme-poverty-because-of-health-expenses [3/1/2024].Google Scholar
WHO (2022) Universal Health Coverage (UHC): www.who.int/news-room/fact-sheets/detail/universal-health-coverage-(uhc) [3/1/2024].Google Scholar
WHO (2023) WHO ambient air quality database, 2022 update: Status report: www.who.int/publications/i/item/9789240047693 [3/1/2024].Google Scholar
Will, C. (2007) The alchemy of clinical trials, BioSocieties, 2: 85–99.10.1017/S1745855207005078CrossRefGoogle Scholar
Will, C., and Moreira, T. (2010) Medical Proofs, Social Experiments. Clinical Trials in Shifting Contexts. Farnham: Ashgate.Google Scholar
Williams, D. J., Thomas, R. J., Hourd, P. C, Chandra, A., Ratcliffe, E., et al. (2012) Precision manufacturing for clinical-quality regenerative medicine. Philosophical Translations of the Royal Society. 28 August. doi:10.1098/rsta.2011.0049 [3/1/2024].CrossRefGoogle Scholar
Wilson, T. A. (2016) Patient groups oppose Senate Regenerative Medicine Bill Wilson, Inside CMS, 19(22): 7–8: www.jstor.org/stable/10.2307/26706144 [3/1/2024].Google Scholar
Windholz, E. L. (2018) Governing through Regulation: Public Policy, Regulation and the Law. Abingdon; New York: Routledge.Google Scholar
WMA (2018) World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects: www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [3/1/2024].Google Scholar
Wohn, Y. (2012) Korea okays stem cell therapies despite limited peer-reviewed data, Nature Medicine, 18, 3, doi:10.1038/nm0312–329a [3/1/2024].CrossRefGoogle ScholarPubMed
WPI (2020) World Premier International Research Center Initiative: www.jsps.go.jp/english/e-toplevel/ [3/1/2024].Google Scholar
Wu Medical Centre (2014) Wu Medical Centre. Every life, every family, every hope: www.wumedicalcenter.com/ [3/1/2024].Google Scholar
Wu, S. W., Chen, T., Wu, M., Pan, Q., Xuan, Y., Wei, L. Y., Wang, Q., Li, C., and Song, J. C. (2016) Management of medical technology under the new medical policy background in China, Chinese Medical Journal, 129(22): 2745–2748: https://doi.org/10.4103/0366-6999.193453 [3/1/2024].CrossRefGoogle ScholarPubMed
Wu, W., Wang, Y., Tang, Z., Gao, Y., and Huo, Y (2020) Regulatory oversight of cell therapy in China: Government’s efforts in patient access and therapeutic innovation, Pharmacological Research, 158: www.sciencedirect.com/science/article/pii/S104366182031197X [3/1/2024].10.1016/j.phrs.2020.104889CrossRefGoogle Scholar
Xie, X., and Ma, M. (2020) Winning in the cell and gene therapies market in China: www2.deloitte.com/content/dam/insights/us/articles/APAC_63550_Winning-in-the-cell-and-gene-therapies/DI_China_CGT_white_paper.pdf [3/1/2024].Google Scholar
Yamakoshi, A. (undated) The changing face of NGOs in Japan: www.gdrc.org/ngo/jpngo-face.html [3/1/2024].Google Scholar
Yamanaka, S. (2020) Perspective – pluripotent stem cell–basedcell therapy: Promise and challenges, Cell Stem Cell, 27(1): 523–531: https://pubmed.ncbi.nlm.nih.gov/33007237/ [3/1/2024].CrossRefGoogle Scholar
Yamasaki, D., and Arai, S. (2014) Japan’s stem-cell therapy progress accelerates, Asian Review, 10 March: http://asia.nikkei.com/Tech-Science/Science/Dainippon-Sumitomo-Pharma-expanding-iPSrelated-operations [3/1/2024].Google Scholar
Yang, J. (2007) Serve the people: Communist ideology and professional ethics of medicine in China. PhD dissertation. Sydney: Faculty of Arts and Social Sciences, University of Technology.Google Scholar
Ye, J., Bates, N., Soteriou, D., Grady, L., Edmond, C., et al. (2017) High quality clinical grade human embryonic stem cell lines derived from fresh discarded embryos, Stem Cell Research & Therapy, 8, 128: https://doi.org/10.1186/s13287–017-0561-y [3/1/2024].CrossRefGoogle ScholarPubMed
Yin, F, Tian, Z. M., Liu, S., Zhao, Q. J., Wang, R. M., Shen, L., et al. (2012) Transplantation of human retinal pigment epithelium cells in the treatment for Parkinson disease, CNS Neuroscience Therapy, 18(12): 1012–1020.CrossRefGoogle ScholarPubMed
Yu, J., Vodyanik, M. A., Smuga-Otto, K., Antosiewicz-Bourget, J., Frane, J. L., Tian, S., Nie, J., Jonsdottir, G. A., Ruotti, V., Stewart, R., Slukvin, I. I., and Thomson, J. A. (2007) Induced pluripotent stem cell lines derived from human somatic cells, Science, 318(5858): 1917–1920.CrossRefGoogle ScholarPubMed
Zhai, X.-M., Ng, V., and Lie, R. (2016) No ethical divide between China and the West in human embryo research, Developing World Bioethics, 16(2): 116–120: https://doi.org/10/f8wcc4 [3/1/2024].CrossRefGoogle ScholarPubMed
Zhai, X.-M., Lei, R., Zhu, W., Qiu, R. (2019) Chinese bioethicists respond to the case of He Jiankui, The Hastings Centre: www.thehastingscenter.org/chinese-bioethicists-respond-case-jiankui/ [3/1/2024].Google Scholar
Zhang, J. (2012) The Cosmopolization of Science: Stem Cell Governance in China. Basingstoke; New York: Palgrave MacMillan.CrossRefGoogle Scholar
Zhang, J. (2017) Lost in translation? Accountability and governance of clinical stem cell research in China, Regenerative Medicine, 12(6): 647–656.10.2217/rme-2017-0035CrossRefGoogle ScholarPubMed
Zhang, J., and Datta-Burton, S. (2021) The Elephant and the Dragon in Contemporary Life Sciences. Basingstoke: Palgrave Macmillan.Google Scholar
Zhihu (2021)两会聚焦干细胞|干细胞等技术将在中国得到快速发展，成都或成”国之重器”发展之地(2021) [Lianghui jujiao ganxibao|ganxibao deng jishu jiang zai zhongguo dedao kuaisu fazahan, chengdu huo cheng ‘guozhi zhongqi’ fazhan zhi di (Two sessions focus on stem cells: Stem cells and other technologies will be developed rapidly in China, and Chengdu may become a place for the development of “the most important tool of the country)]: https://zhuanlan.zhihu.com/p/356039878 [3/1/2024].Google Scholar
Zhongyuan Union (2014) 中源协和细胞基因工程股份有限公司 关于收购深圳市北科生物科技有限公司13%股权的公告 [Zhongyu Xiehe xibao-jiin goncheng gufen youxiancongsi guanyu shogou Shenzhen-Shi Beike Shenwu Keji Youxian Gongsi 13% guquan de gonggao]: http://data.eastmoney.com/notices/detail/600645/AN201412220007970166,JUU0JUI4JUFEJUU2JUJBJTkwJUU1JThEJThGJUU1JTkyJThD.html [3/1/2024].Google Scholar

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