Medical innovation and national experimental pluralism: Insights from clinical stem cell research and applications in China

BioSocieties

Volumn 8, Issue 1, 2013, Pages 58-74

  Rosemann, Achim ^a  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

Author keywords

China; Clinical stem cell research; Evidence based medicine; Science regulation; Scientific standards; Translational research

Indexed keywords

EID: 84873913532     PISSN: 17458552     EISSN: 17458560     Source Type: Journal    
DOI: 10.1057/biosoc.2012.39     Document Type: Article

References (51)

1. BBC Panorama. (2009) Stem cells and miracles. TV documentary, http://www.bbc.co.uk/programmes/b00kmltm, accessed 11 December 2012.
2. CCTV. (2002) Hope for the cure of Spinal Cord Injury. Transcript of TV program (in Chinese). CCTV 10, 4 February. Program name: Jiangkang Zhilu [The Healthy Way], http://www.cctv.com/life/jiankangzhilu/index020204.html, accessed 12 August 2011.
3. CCTV. (2003) Chinese biotechnology moves further to the next level. Transcript of TV program (in Chinese). CCTV 4, 20 February. Program name: Zhongguo Baodao [China Report], http://www.cctv.com/lm/522/more41.html, accessed 12 August 2011.
4. CCTV. (2007) A 38 year old paraplegic relearns to walk after calamity caused by collapsing building. TV program. CCTV 10, 19 January. Program name: Jiangkang Zhilu [The Healthy Way], http://discovery.cctv.com/20070119/104142. shtml, accessed 12 August 2011.
5. CCTV. (2010) Stem cell transplantation therapy expert: YANG Xiaofeng. TV program. CCTV 10, 11 June. Program name: Keji Renwu [Science & Technology Life], http://www.ihealth.org.cn/article-1087-2.html, accessed 12 August 2011.
6. Chen, D.F. (2010) The application of stem cell transplantation in acute and sub-acute liver failure. Conference Presentation (unpublished). Workshop of Frontiers Cell Therapy Research, Tianjin, 24 September.
7. Chen, H. (2009) Stem cell governance in China: From bench to bedside? New Genetics and Society 28(3): 267-282.
8. Chen, S. et al (2004) Effect on left ventricular function of intracoronary transplantation of autologous bone marrow mesenchymal stem cell in patients with acute myocardial infarction. American Journal of Cardiology 94(1): 92-95.
9. CURE. (2009) Medical Research Council: CURE Committee Report, http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC006303, accessed 9 April 2011.
10. Cyranoski, D. (2009) Stem-cell therapy faces more scrutiny in China: But regulations remain unclear for companies that supply treatments. Nature 459(7244): 146-147.
11. Cyranoski, D. (2012) China's stem cell rules go unheeded. Nature 484(7393): 149-150.
12. Ding, J.X., Xue, Y.J., Liang, H.H.G., Shao, R. and Chen, Y.F. (2011) From imitation to innovation: A study of China's drug R&D and relevant national policies. Journal of Technology Management Innovation 6(2): 1-13.
13. DoH. (2008) World Medical Association Declaration of Helsinki, http://www.wma.net/en/30publications/10policies/b3/, accessed 12 August 2011.
14. EMA. (2012) Reflections paper on classification of advanced therapy medicinal products, http://www.ema.europa.eu/docs/en-GB/document-library/ Regulatory-and-procedural-guideline/2012/04/WC500126681.pdf, accessed 3 August 2012.
15. Faulkner, A. (2009) Regulatory policy as innovation. Research Policy 38(4): 37-646.
16. Gong, W. et al (2012) Banking human umbilical cord-derived mesenchymal stromal cells for clinical use. Cell Transplantation 21(1): 07-216.
17. Gu, Y.Q. et al (2003) Treatment of diabetic foot with autologous bone marrow cells: A case report. Zhong Guo Shi Yong Wai Ke Za Zhi [Chinese Journal of Practical Surgery] 23: 670.
18. Hu, C.L. (2010) Ethical guidelines for the clinical research and application of stem cells, http://wenku.baidu.com/view/f52fd4886529647d27285223. html, accessed 11 August 2011.
19. Huang, Q. (2007) Fact inquiry of stem cells: 'Gambling' on the hospital bed. New People's Weekly, 20 September, http://scitech.people.com.cn/GB/6290699. html, accessed 11 August 2011.
20. Hyun, I.S. (2010) Allowing room for innovative stem cell-based therapies outside clinical trials: Ethical and practical challenges. Journal of Law, Medicine, and Ethics 38(2): 277-285.
21. ISSCR. (2008) ISSCR guidelines for the clinical translation of stem cells, http://www.isscr.org/GuidelinesforClinicalTranslation/2480.htm, accessed 15 July 2012.
22. Jiang, R.H. et al (2011) Transplantation of placenta-derived mesenchymal stem cells in type 2 diabetes: A pilot study. Frontiers of Medicine 5(1): 94-100.
23. Li, J.J. (2011) GCP implementation status in China. Presentation State Food and Drug Administration, http://www.pmda.go.jp/english/events/2010-sympo/ file/201005-04.pdf, accessed 13 August 2011.
24. Li, J.M. et al (2010) Human mesenchymal stem cell transplantation protects against cerebral ischemic injury. Brain Research 1334: 65-72.
25. Li, Y.I., Su, X. and Wang, L. (2008) Evidence-based medicine in China. Value in Health 11(1): 156-158.
26. Li, Z. et al (2007) The clinical study of autologous peripheral blood stem cell transplantation by intracoronary infusion in patients with acute myocardial infarction. International Journal of Cardiology 115(1): 2-56.
27. Liao, L.M. and Zhao, C.H. (2008) An overview of stem cell based clinical trials in China. Stem Cells and Development 17(4): 613-618.
28. Liu, H.Z. and Xing, R.J. (2002) Neural stem cell transplantation: Cerebral palsy successful. Xinhua News Agency, 16 January.
29. The Chinese Ministry of Health (MOH). (2012) Notification on self-evaluation and self-correction work regarding the development of clinical stem cell clinical research and applications [Guanyu kaizhan ganxibao linchuang yanjiu he yingyong zicha zijiu gongzuo de tongzhi]. www.moh.gov.cn/publicfiles/ business/htmlfiles/mohkjjys/s3582/201201/53890.htm, accessed 11 December 2012.
30. Nanfang Zhoumo [Southern Weekend]. (2006) Huang hongyun: Striking breakthrough or science bubble. 21 July, http://www.bioon.com/biology/chinese/ 185809.shtml, accessed 14 May 2011.
31. Ong, A. (2010) Introduction. In: A. Ong and N.N. Chen (eds.) Asian Biotech. Durham, NC: Duke University Press, pp. 1-51.
32. Peng, Y., Hu, D.R., Wang, S., Wen, W., Zhou, Y.M. and Gong, L.J. (2005) Treatment for patients with severe liver damage by transplantation of autologous bone marrow stem cells. Shiyong Yixue Zazhi [Journal of Practical Medicine] 17(19): 143-2145.
33. Peng, Z.H., Qing, Y. and Li, B. (2008) The application of gene therapy in China. Drugs 11(5): 346-350.
34. Qiu, J. (2009) Trading on hope. Nature Biotechnology 27(9): 790-792.
35. Qiu, X.X. et al (2010) Ganxibao yanjiu yu yingyong zhong lilun wenti de zaizhoucha: jieguo yu jianyi [Reinvestigation on ethical issues in stem cell research and clinical use: Results and Recommendations].
36. Yixue yu Zhexue: Renwen Shehuiyixue [Medicine & Philosophy: Humanistic & Social Medicine Edition] 31(2): 5-18.
37. RJS (RJS Medical Technology Inc). (2010) Introduce of China SFDA, http://www.sfdachina.com/info/50-1.htm, accessed 11 August 2011.
38. Rosemann, A. (2012) Multi-polar Technoscience: Clinical science collaborations in a changing world system. PhD Dissertation, University of Sussex.
39. Salter, B. and Qiu, R.Z. (2009) Bioethical governance and basic stem cell science: China and the global biomedicine economy. Science and Public Policy 36(1): 47-59.
40. Sipp, D. (2012) Clinical translation of stem cell research in Asia: Strides forward and missteps. Invited Lecture, Sussex University, 19 April.
41. Sleeboom-Faulkner, M. (2010) Embryo controversies and governing stem cell research in Japan. In: A. Ong and N.N. Chen (eds.) Asian Biotech. Durham, NC: Duke University Press, pp. 215-237.
42. Song, P. (2010) Biotech pilgrims and the transnational quest for stem cell cures. Medical Anthropology 29(4): 384-402.
43. Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: Problematizing ethical regulation. New Genetics and Society 30(2): 141-153.
44. Tang, J.L., Liu, B.Y. and Ma, K.W. (2008) Traditional Chinese medicine. Lancet 372(9284): 938-940.
45. Tang, Y. et al (2012) Cell viability and dopamine secretion of 6-hydroxydopamine-treated PC12 cells co-cultured with bone marrow-derived mesenchymal stem cells. Neural Regeneration Research 7(14): 1101-1105.
46. Timmermans, S. and Epstein, S. (2011) A world of standards but not a standard world: Toward a sociology of standards and standardization. Annual Review of Sociology 36: 9-89.
47. Van Zwanenberg, P., Ely, A. and Smith, A. (2011) Regulating Technology. London: Earthscan.
48. Wang, S. (2009) Chongqing: The first successful case of autologous bone marrow stem cell treatment for liver cirrhosis. Newsletter Daping Hospital, Research Institute of Surgery.
49. Wang, X. et al (2007) Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: A pilot randomized controlled trial. Journal of the American College of Cardiology 49(14): 566-1571.
50. Webster, A., Haddad, C. and Waldby, C. (2011) Experimental heterogeneity and standardisation: Stem cell products and the clinical trial process. BioSocieties 6(4): 401-419.
51. Zhu, J.H., Zhou, L.F., Ge, F. andWu, X. (2006) Tracking neural stem cells in patients with brain trauma. New England Journal of Medicine 355(22): 376-378.