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References Abbott, A. 2013. Stem-cell ruling riles researchers. Nature 495(7442):418–419. Abbott, A. 2014. Leaked files slam stem-cell therapy. Nature 505(7482):139– 140. Amariglio, N., A. Hirshberg, B. W. Scheithauer, Y. Cohen, R. Loewenthal, L. Trakhtenbrot, N. Paz, M. Koren-Michowitz, D. Waldman, L. Leider-Trejo, A. Toren, S. Constantini, and G. Rechavi. 2009. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Medicine 6(2):e1000029. Arellano, M. 2012. The rise of stem cell therapies in Mexico: Inadequate regulation or unsuccessful oversight? Revista Redbioética/UNESCO 3(2):63–78. ASRM (American Society for Reproductive Medicine). 2013. Definition of experimental procedures: A committee opinion. Fertility and Sterility 99(5):1197–1198. Barclay, E. 2009. Stem-cell experts raise concerns about medical tourism. Lancet 373(9667):883–884. Bianco, P. 2013. Don’t market stem-cell products ahead of proof. Nature 499(7458):255. Bohgaki, T., T. Atsumi, and T. Koike. 2007. Multiple autoimmune diseases after autologous stem-cell transplantation. New England Journal of Medicine 357(26):2734–2736. Caulfield, T., C. Rachul, and A. Zarzeczny. 2012. The evolution of policy issues in stem cell research: An international survey. Stem Cell Reviews 8(4):1037–1042. CBER (Center for Biologics Evaluation and Research). 2011. Center for Biologics Evaluation and Research strategic plan, FY 2012–2016. http://www.fda.gov/ downloads/aboutfda/centersoffices/cber/ucm266867.pdf (accessed March 25, 2014). Chen, H., and H. Gottweis. 2013. Stem cell treatments in China: Rethinking the patient role in the global bio-economy. Bioethics 27(4):194–207. 55

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56 STEM CELL THERAPIES Connell, J. 2011. A new inequality?: Privatisation, urban bias, migration and medical tourism. Asia Pacific Viewpoint 52(3):260–271. Cyranoski, D. 2009. Stem-cell therapy faces more scrutiny in China. Nature 459(7244):146–147. Cyranoski, D. 2010. Korean deaths spark inquiry. Nature 468(7323):485. Cyranoski, D. 2012. China’s stem-cell rules go unheeded. Nature 484(7393): 149–150. Daley, G. Q. 2012. The promise and perils of stem cell therapeutics. Cell Stem Cell 10(6):740–749. Dobkin, B. H., A. Curt, and J. Guest. 2006. Cellular transplants in China: Observational study from the largest human experiment in chronic spinal cord injury. Neurorehabilitation and Neural Repair 20(1):5–13. Dominici, M., K. Le Blanc, I. Mueller, I. Slaper-Cortenbach, F. Marini, D. Krause, R. Deans, A. Keating, D. Prockop, and E. Horwitz. 2006. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 8(4):315–317. EMA (European Medicines Agency). 2007. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council. http://ec.europa.eu/health/ files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf (accessed March 7, 2014). FDA (U.S. Food and Drug Administration). 1997. Proposed approach to regulation of cellular and tissue-based products. http://www.fda.gov/downloads/Biologics BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ UCM062601.pdf (accessed March 11, 2014). FDA. 2009. Regenerative Services, Inc. http://www.fda.gov/biologicsbloodvaccines/ guidancecomplianceregulatoryinformation/complianceactivities/enforcement/ untitledletters/ucm091991.htm (accessed March 6, 2014). FDA. 2012. FDA warns about stem cell claims. http://www.fda.gov/forconsumers/ consumerupdates/ucm286155.htm (accessed March 10, 2014). FDA. 2013. Tissue reference group. http://www.fda.gov/biologicsbloodvaccines/ tissuetissueproducts/regulationoftissues/ucm152857.htm (accessed March 6, 2014). Fine, J. D., R. A. Eady, E. A. Bauer, J. W. Bauer, L. Bruckner–Tuderman, A. Heagerty, H. Hintner, A. Hovnanian, M. F. Jonkman, I. Leigh, J. A. McGrath, J. E. Mellerio, D. F. Murrell, H. Shimizu, J. Uitto, A. Vahlquist, D. Woodley, and G. Zambruno. 2008. The classification of inherited epidermolysis bullosa (EB): Report of the Third International Consensus Meeting on Diagnosis and Classification of EB. Journal of the American Academy of Dermatology 58(6):931–950. George, D. 2012. Mexico: A new legislation for stem cell therapies. Medical Tourism Magazine. http://www.medicaltourismmag.com/mexico-a-new-legislation-for- stem-cell-therapies (accessed April 24, 2014).

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