Stem Cell Clinical Trials for Spinal Cord Injury: Readiness, Reluctance, Redefinition
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A wealth of scientific and clinical research has focused on the use of stem cells as a potential therapy for spinal cord injury (SCI), culminating most recently in the initiation of clinical trials. However, with the urgency that scientists and clinicians have undertaken to move forward with novel therapies for this devastating injury, the perspectives of stakeholders who live with a SCI have been left behind. Translational research in this rapidly growing field therefore overlooks a critically important viewpoint. We address this concern with a qualitative study of the perspectives on experimental stem cell treatments from individuals who have actually suffered a spinal cord injury. Using focus groups and interviews, we engaged individuals with thoracic and cervical SCIs at sub-acute and chronic stages post-injury. We found four major themes that inform the progression of stem cell research to clinical trials: ‘readiness’, ‘the here and now’, ‘wait and see’, and ‘informed hope’. Taken together, the data suggest a profound difference related to target timing of stem cell clinical trials and the perspectives about timing from those who are the end-beneficiaries of therapy. To bridge this gap, we conclude with a number of considerations for the timing disparity of trials and recommendations for improving informed consent.
- Tetzlaff, W., Okon, E., Karimi-Abdolrezaee, S., et al. (2010). A systematic review of cellular transplantation therapies for spinal cord injury. Journal of Neurotrama. doi:10.1089/neu.2009.1177.
- Kwon, B., Sekhon, L., & Fehlings, M. (2010). Emerging repair, regeneration and translational research advances for spinal cord injury. Spine, 35(21S), S263–S270. CrossRef
- Sahni, V., & Kessler, J. (2010). Stem cell therapies for spinal cord injury. Nature Reviews Neurology, 6, 363–372. CrossRef
- International Campaign for Cures of spinal cord injury paralysis. (2010). General Information. http://www.campaignforcure.org/iccp/index.php? option = com_content&task = view&id = 13&Itemid = 28. Accessed January 2010.
- Downey, R., & Geranser, R. (2008). Stem cell research, publics’ and stakeholder views. Health Law Review, 16(2), 9–84.
- Abma, T. (2005). Patient participation in health research: research with and for people with spinal cord injuries. Qualitative Health Research, 15(10), 1310–1328. CrossRef
- Grunwell, J., Illes, J., & Karkazis, K. (2009). Advancing neuroregenerative medicine: A call for expanded collaboration between scientists and ethicists. Neuroethics, 2(1), 13–20. CrossRef
- Estores, I. (2003). The consumer’s perspective and the professional literature: what do persons with spinal cord injury want? Journal of Rehabilitation Research and Development, 40(4), 93–98. CrossRef
- Anderson, K. (2003). Consideration of user priorities when developing neural prosthetics. Journal of Neural Engineering, 6(5), 1–3.
- Kwon, B., Hillyer, J., & Tetzlaff, W. (2010). Translational research in spinal cord injury: a survey of opinion from the SCI community. Journal of Neurotrauma, 27, 21–33. CrossRef
- Geron initiates clinical trial of human embryonic stem cell-based therapy. (2010). Press release. http://www.geron.com/media/pressview.aspx?id=1235. Accessed 17 November 2010.
- Keirstead, H. S., Nistor, G., Bernal, G., Totoiu, M., Cloutier, F., Sharp, K., et al. (2005). Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants remyelinate and restore locomotion after spinal cord injury. Journal of Neuroscience, 11(19), 4694–4705. CrossRef
- Kumar, A. A., Kumar, S. R., Narayanan, R., Arul, K., & Baskaran, M. (2009). Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: a phase I/II clinical safety and primary efficacy data. Experimental and Clinical Transplantation, 7(4), 241–248.
- Pal, R., Venkataramana, N. K., Bansal, A., et al. (2009). Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study. Cytotherapy, 11(7), 897–911. CrossRef
- Yoon, S. H., Shim, Y. S., Park, Y. H., et al. (2007). Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor: Phase I/II clinical trial. Stem Cells, 25(8), 2066–2073. CrossRef
- Cristante, A. F., Barros-Filho, T. E., Tatsui, N., et al. (2009). Stem cells in the treatment of chronic spinal cord injury: Evaluation of somatosensitive evoked potentials in 39 patients. Spinal Cord, 47(10), 733–8. CrossRef
- Chernykh, E. R., Stupak, V. V., Muradov, G. M., et al. (2007). Application of autologous bone marrow stem cells in the therapy of spinal cord injury patients. Bulletin of Experimental Biology and Medicine, 143(4), 543–547. CrossRef
- Moviglia, G. A., Fernandez Viña, R., Brizuela, J. A., et al. (2006). Combined protocol of cell therapy for chronic spinal cord injury. Report on the electrical and functional recovery of two patients. Cytotherapy, 8(3), 202–209. CrossRef
- Lima, C., Escada, P., Pratas-Vital, J., et al. (2010). Olfactory mucosal autografts and rehabilitation for chronic traumatic spinal cord injury. Neurorehabilitation and Neural Repair, 24(1), 10–22. CrossRef
- Mackay-Sim, A., Féron, F., Cochrane, J., et al. (2008). Autologous olfactory ensheathing cell transplantation in human paraplegia: A 3-year clinical trial. Brain, 131(9), 2376–2386. CrossRef
- ReNeuron announces first patient treated in landmark stroke stem cell trial. (2010). Press Release. http://www.reneuron.com/news__events/news/document_260_237.php. Accessed 20 November 2010.
- van Hedel, H. J., & Curt, A. (2006). Fighting for each segment: Estimating the clinical value of cervical and thoracic segments in SCI. J Neurotrauma, 23(11), 1621–1631. CrossRef
- Bradley, E., Curry, L., & Devers, K. (2007). Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Services Research, 42(4), 1758–1772. CrossRef
- Thorne, S., Kirkham, S. R., O’Flynn-Magee, K. (2004) The analytic challenge in interpretative description. International Journal of Qualitative Methods. 3(1). Accessed 18 February 2011, http://www.ualberta.ca/%7Eiiqm/backissues/3_1/ pdf/thorneetal.pdf
- Feudtner, C. (2008). Ethics in the midst of therapeutic evolution. Archives of Pediatric Adolescent Medicine, 162(9), 854–857. CrossRef
- Robertson, J. (2010). Embryo stem cell research: Ten years of controversy. The Journal of Law, Medicine and Ethics, 38(2), 191–203. CrossRef
- Taylor, C. (2010). Overseeing innovative therapy without mistaking it for research: a function based model based on old truths, new capacities and lessons learned from stem cells.). Embryo stem cell research: ten years of controversy. The Journal of Law, Medicine and Ethics, 38(2), 286–301. CrossRef
- Angiolillo, A. L., Simon, C., Kodish, E., Lange, B., Noll, R. B., Ruccione, K., et al. (2004). Staged informed consent for a randomized clinical trial in childhood leukemia: Impact on the consent process. Pediatric Blood Cancer, 42, 433–437. CrossRef
- Edner, M., Yamokoski, A., Wittman, P., & Kodish, E. (2007). Improving informed consent: Suggestions from parents. Pediatrics, 119(4), e849–e859. CrossRef
- Lavori, P., Sugarman, J., Hays, M., & Feussner, J. (1999). Improving informed consent in clinical trials: A duty to experiment. Controlled Clinical Trials, 20(2), 187–193. CrossRef
- Francis, V., Korsch, B. M., & Morris, M. J. (1969). Gaps in the doctor–patient communication: Patients’ respond to medical advice. New England Journal of Medicine, 80(10), 535–540. CrossRef
- Joffe, S., Cook, E. F., Cleary, P. D., et al. (2001). Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet, 358, 1771–1777. CrossRef
- Sugarman, J. (2010). Reflections on governance models for the clinical translation of stem cells. Journal of Law, Medicine and Ethics, 38(2), 251–256. CrossRef
- Wade, J., Donovan, J., Lane, J. A., Neal, D., & Hamdy, F. (2009). It’s not just what you say, it’s how you say it: opening the ‘black box’ of informed consent appointments in randomized controlled trials. Social Science and Medicine, 68, 2018–2028. CrossRef
- Barfield, R. C., & Church, C. (2005). Informed consent in pediatric clinical trials. Current Opinion in Pediatrics, 17(1), 20–24. CrossRef
- Stem Cell Clinical Trials for Spinal Cord Injury: Readiness, Reluctance, Redefinition
Stem Cell Reviews and Reports
Volume 7, Issue 4 , pp 997-1005
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- Humana Press Inc
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- Author Affiliations
- 1. Division of Neurology, Department of Medicine, National Core for Neuroethics, University of British Columbia, 2211 Wesbrook Mall Koerner Pavilion, Room S124, Vancouver, BC, V6T 2B5, Canada
- 2. National Core for Neuroethics, University of British Columbia, 2211 Wesbrook Mall Koerner Pavilion, Room S124, Vancouver, BC, V6T 2B5, Canada
- 3. Department of Orthopaedics, Combined Neurosurgical and Orthopaedic Spine Program, University of British Columbia, Vancouver, Canada