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Review | Open Access

Overview of ethical issues for conducting neuroprotective clinical trials in patients with spinal cord injury

Hooshang Saberi1,2( ), Nazi Derakhshanrad1, Mahsa Ghajarzadeh1
Brain and Spinal Cord Injury Research Center, Imam Khomeini Hospital,
Department of Neurosurgery, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
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Abstract

Animals have been used in medical and biological researches worldwide for long time. Almost all of these studies are published with the hope of clinical application. However, there are meticulous criteria considering results of animal studies in clinical trials of human beings. In recent years, the number of experimental research in animal models of spinal cord injury has been growing. However, there is no warranty for translation of experimental studies into clinical practice. Certain protocols should be considered in all phases of conducting clinical trials such as study design, data gathering, and analysis. In this article, we comprehensively review different aspects of ethical issues in translating results of animal studies into clinical application, especially in patients with spinal cord injury.

Keywords

spinal cord injuryneuroprotective treatmentanimal studiestranslation

References

1.
Karimi-Abdolrezaee S, Eftekharpour E, Wang J, Morshead CM, Fehlings MG. Delayed transplantation of adult neural precursor cells promotes remyelination and functional neurological recovery after spinal cord injury. J Neurosc. 2006;26(13):3377–3389.
Crossref Google Scholar
2.
Matthews RA. Medical progress depends on animal models-doesn’t it? J R Soc Med. 2008;101(2):95–98.
Crossref Google Scholar
3.
Hackam DG, Redelmeier DA. Translation of research evidence from animals to humans. JAMA. 2006;296(14):1727–1732.
Crossref Google Scholar
4.
Perel P, Roberts I, Sena E, et al. Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ. 2007;334(7586):197.
Crossref Google Scholar
5.
Hackam DG. Translating animal research into clinical benefit. BMJ. 2007;334(7586):163–164.
Crossref Google Scholar
6.
Guest J, Harrop JS, Aarabi B, et al. Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network. J Neurosurg Spine. 2012;17(1 Suppl):94–101.
Crossref Google Scholar
7.
Fawcett JW, Curt A, Steeves JD, et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. Spinal Cord. 2006;45(3):190–205.
Crossref Google Scholar
8.
Schaller B, Graf R, Wienhard K, Heiss W. A new animal model of cerebral venous infarction: ligation of the posterior part of the superior sagittal sinus in the cat. Swiss Med Wkly. 2003;133(29/30):412–418.
Google Scholar
9.
Schaller B, Graf R, Sanada Y, et al. Hemodynamic changes after occlusion of the posterior superior sagittal sinus: an experimental PET study in cats. Am J Neuroradiol. 2003;24(9):1876–1880.
Google Scholar
10.
van der Worp HB, Howells DW, Sena ES, et al. Can animal models of disease reliably inform human studies? PLoS Med. 2010;7(3): e1000245.
Crossref Google Scholar
11.
Rosenfeld JV, Bandopadhayay P, Goldschlager T, Brown DJ. The ethics of the treatment of spinal cord injury: stem cell transplants, motor neuroprosthetics, and social equity. Top Spinal Cord Inj Rehabil. 2008;14(1):76–88.
Crossref Google Scholar
12.
Tuszynski MH, Steeves JD, Fawcett JW, et al; International Campaign for Cures of Spinal Cord Injury Paralysis. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial inclusion/exclusion criteria and ethics. Spinal Cord. 2007;45(3):222–231.
Crossref Google Scholar
13.
Fehlings MG, Vawda R. Cellular treatments for spinal cord injury: the time is right for clinical trials. Neurotherapeutics. 2011;8(4):704–720.
Crossref Google Scholar
14.
Mackay-Sim A, Féron F, Cochrane J, et al. Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial. Brain. 2008;131(9):2376–2386.
Crossref Google Scholar
15.
Illes J, Reimer JC, Kwon BK. Stem cell clinical trials for spinal cord injury: readiness, reluctance, redefinition. Stem Cell Rev. 2011;7(4):997–1005.
Crossref Google Scholar
16.
Saberi H, Firouzi M, Habibi Z, et al. Safety of intramedullary Schwann cell transplantation for postrehabilitation spinal cord injuries: 2-year follow-up of 33 cases: clinical article. J Neurosurg Spine. 2011;15(5):515–525.
Crossref Google Scholar
Journal of Neurorestoratology
Volume 3 Issue 1,
December 2015
Pages 97-100
DOI: 10.2147/JN.S74137
Cite this article:
Saberi H, Derakhshanrad N, Ghajarzadeh M. Overview of ethical issues for conducting neuroprotective clinical trials in patients with spinal cord injury. Journal of Neurorestoratology, 2015, 3(1): 97-100. https://doi.org/10.2147/JN.S74137

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Published: 06 May 2015
© 2015 The Author(s).

© 2015 Saberi et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php
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