Which patient groups should be asked to participate in first-in-human trials of stem-cell-based therapies?

Journal of Clinical Ethics

Volumn 23, Issue 3, 2012, Pages 256-271

  Hug, Kristina ^a   Hermerén, Goran ^a  

^a LUND UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CAREGIVER; COST OF ILLNESS; DECISION MAKING; ETHICS; FAMILY RELATION; HUMAN; HUNTINGTON CHOREA; LIFE EXPECTANCY; MENTAL STRESS; NURSING; PARKINSON DISEASE; PATIENT SELECTION; PERSONHOOD; PHASE 1 CLINICAL TRIAL (TOPIC); PSYCHOLOGICAL ASPECT; QUALITY OF LIFE; STEM CELL TRANSPLANTATION;

CAREGIVERS; CLINICAL TRIALS, PHASE I AS TOPIC; COST OF ILLNESS; DECISION MAKING; FAMILY RELATIONS; HUMANS; HUNTINGTON DISEASE; LIFE EXPECTANCY; PARKINSON DISEASE; PATIENT SELECTION; PERSONHOOD; QUALITY OF LIFE; STEM CELL TRANSPLANTATION; STRESS, PSYCHOLOGICAL;

EID: 84872044683     PISSN: 10467890     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (42)

1. J. A. Robertson, "Embryo stem cell research: ten years of controversy", Journal of Law, Medicine and Ethics 38, no. 2(2010):191-203.
2. D. Magnus, "Translating stem cell research: challenges at the research frontier", Journal of Law, Medicine and Ethics 38, no. 2(2010):267-76.
3. R. K. Fung and L. H. Kerridge, "Uncertain translation, uncertain benefit and uncertain risk: Ethical challenges facing first-in-human trials of induced pluripotent stem (IPS) cells", Bioethics (4 July 2011): doi: 10.1111/j.1467-8519.2011.01896.x, epub ahead of print.
4. K. Hug and A. Castor, "Experimental Stem Cell-Based Therapy in Pediatrics: A Fictional Case Study", Translational Stem Cell Research: Issues Beyond the Debate on the Moral Status of the Human Embryo, ed. K. Hug and G. Hermerén (New York: Springer, 2011), 151-49.
5. J. Sugarman, "Ethics and Stem Cell Therapeutics for Cardiovascular Disease", Progress in Cardiovascular Diseases 50, no. 1(July-August 2007):1-6; (Pubitemid 47044937)
6. J. Sugarman, "Human Stem Cell Ethics: Beyond the Embryo Cell", Cell Stem Cell 2, no. 6(2008):529-33. (Pubitemid 351729218)
7. Sugarman, "Ethics and Stem Cell Therapeutics for Cardiovascular Disease", ibid.
8. J. Kimmelman et al., "Launching Invasive, First-in-Human Trials Against Parkinson's Disease: Ethical Considerations. Movement Disorders", 24, no. 13(2009):1893-901.
9. International Society for Stem Cell Research, ISSCR Guidelines for the Clinical Translation of Stem Cells. December 3, Part 5(2008), http://www.isscr.org/clinical-trans/pdfs/ISSCRGLClinical Trans.pdf, accessed 12 March 2010.
10. O. Lindvall and Z. Kokaia, "Stem cells in human neurodegenerative disorders-time for clinical translation?" Journal of Clinical Investigation 120, no. 1(2010):29-40.
11. O. Lindvall and A. Björklund, "Cell Therapy in Parkinson's Disease", NeuroRx 1, no. 4(2004):382-93. (Pubitemid 46589366)
12. Y.-P. Wu, W-S. Chen, C. Teng, and N. Zhang, "Stem Cells for the Treatment of Neurodegenerative Diseases", Molecules 15, no. 10(2010):6743-58;
13. O. Lindvall and Z. Kokaia, "Stem cells for the treatment of neurological disorders", Nature 411, no. 7097(29 June 2006):1094-6. (Pubitemid 43990722)
14. P. Hagell et al., "Health-related quality of life following bilateral intrastriatal transplantation in Parkinson's disease", Movement Disorders 15, no. 2(2000):224-9. (Pubitemid 30166727)
15. K. Hug and G. Hermerén, "Do we still need human embryonic stem cells for stem cell-based therapies? Epistemic and ethical aspects", Stem Cell Reviews and Reports 7, no. 4(2011):761-74.
16. K. Fleischhauer and G. Hermerén, Goals of Medicine in the Course of History and Today: A Study in the History and Philosophy of Medicine (Stockholm: Kungl. Vitterhets Historie och Antikvitets Akademien, 2006).
17. Sugarman, "Human Stem Cell Ethics: Beyond the Embryo", see note 12 above.
18. WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects (2008), http://www.wma.net/en/30publications/ 10policies/b3/, article 31, accessed 14 March 2010.
19. See note 15 above, recommendation 24.
20. See note 39 above, article 35.
21. See note 15 above, recommendation 25.
22. See note 15 above, recommendation 26.
23. European Parkinson's Disease Association (EPDA), Life with Parkinson's (2008), http://www.oursocialmedia.com/wp-content/uploads/epda-Iife-with- parkinsons-front-cover.pdf, accessed 12 June 2010.
24. Kelly B., "Relocating", 2009, http://www.rule domain. com/hdac/features/article.php?p-articleNumber=635, accessed 12 June 2010.
25. P. S. Harper, Huntington's Disease (London: W. B. Saunders, 1996).
26. H. W. Krohne, Attention and Avoidance: Strategies in Coping with Aversiveness (Seattle: Hogrefe and Huber, 1993).
27. F. O. Walker, "Huntington's disease", Lancet 369, no. 9557(20 January 2007):218;
28. R. M. Bonelli, G. K. Wenning, and H. P. Kapfhammer, "Huntington's disease: present treatments and future therapeutic modalities", International Clinical Psychopharmacology 19, no. 2(2004):51-62. (Pubitemid 38316763)
29. O. Lindvall and Z. Kokaia, "Prospects of stem cell therapy for replacing dopamine neurons in Parkinson's disease", Trends in Pharmacological Sciences 30, no. 5(2009):260-8;
30. J. Nolta, "Working Toward Mesenchymal Stem Cell Therapy for HD", Neurotherapeutics 7, no. 1(2010):136.
31. L. Findley and M. Baker, "Impact of Parkinson's Disease on Patient Participation in Daily Life: Results of an International Survey", EPDA, 1999, http://www.parkinsons.org.pk/download/ Impact%20of%20Parkinson's%20Disease%20 on%20Patient%20Participation%20in%20Daily %20Life.pdf, accessed 18 August 2012
32. European Parkinson's Disease Association (EPDA), Participation in Life Survey-Results, 1999, http://www.epda.eu.com/en/resources/publicationsand-web- database/?entryid2=3620&q=0%7eParticipation+in+life%7e, accessed 18 August 2012.
33. European Parkinson's Disease Association (EPDA), 2010, http://www.epda.eu.com, accessed 18 August 2012.
34. European Parkinson's Disease Association (EPDA), Q&A. Fabrizio Stocchi and Bastiaan Bloem 2009, http://www.epda.eu.com/en/resources/epdaextra/, accessed 18 August 2012.
35. Kelly B., "Confronting Fate", 2009, http://www.ruledomain. com/hdac/features/article.php?p-articleNumber=622, accessed 18 August 2012.
36. M. Bloch et al., Predictive testing for Huntington's Disease in Canada: the experiences of those receiving a increased risk", American Journal of Medical Genetics 43(1992):499-507.
37. A. Lowit and E. van Teijlingen, "Avoidance as a strategy of (not) coping: qualitative interviews with carers of Huntington's Disease patients", BMC Family Practice 6, no. 1(2005):38.
38. J. Korer and J. S. Fitzsimmons, "The effect of Huntington's Chorea on family life", British Journal of Social Work 15(1985):581-97.
39. European Parkinson's Disease Association (EPDA), "Case Study. Italy and the Netherlands, 'A tale of two countries'", http://www.epda.eu.com, accessed 26 January 2010.
40. S. Kessler, "Forgotten person in the Huntington's Disease family", American Journal of Medical Genetics 48(1993):145-50. (Pubitemid 23292008)
41. WHO, Neurological Disorders-Public Health Challenges, (2006), http://www.who.int/mental-health/neurology/neurological-disorders-report-web. pdf accessed 13 January 2010.
42. University of North Texas, "IRB Procedures: Risks that Must be Clearly Assessed and Described in the Application", 2012, http://research.unt.edu/faculty-resources/research-integrity-and-compliance/ use-of-humans-in-research/unt-irb-procedures #risks, accessed 13 April 2012.