Perfused human organs versus Mary Shelley's Frankenstein
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BioMed Central
Open Access
Commentary
Perfused human organs versus Mary Shelley's Frankenstein Lawrence Leung Address: Department of Family Medicine, Queen's University, 220 Bagot Street, PO Bag 8888, Kingston Ontario K7L 5E9, Canada Email: Lawrence Leung - [email protected]
Published: 23 January 2009 Journal of Translational Medicine 2009, 7:9
doi:10.1186/1479-5876-7-9
Received: 19 January 2009 Accepted: 23 January 2009
This article is available from: http://www.translational-medicine.com/content/7/1/9 © 2009 Leung; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Novel drugs have to go through mandatory pre-clinical testing before they can be approved for use in clinical trials. In essence, it is a form of bench-to-bedside (N2B) translational medicine, but the wastage rate of target candidates is immensely high. Effects seen in vitro often do not translate to in vivo human settings. The search is on for better models closer to human physiology to be used in pre-clinical drug screening. The Ex Vivo Metrics© system has been introduced where a human organ is harvested and revitalized in a controlled environment suitable for testing of both drug efficacy and potential toxicity. This commentary expresses the author's views regarding this technology of perfused human organs.
Introduction Every new drug has to undergo Phase 1/2 clinical trials, where the safety and toxicity profile have to be clearly established before it can proceed to larger scale Phase 3/4 trials. Before entering any clinical phase, pre-clinical data would have to be procured from cultured cell-lines and tissues, in addition to animal models in the laboratories. However, no matter how good these models are, pre-clinical data may not be directly conversant with the natural physiology and processes of living human beings. This accounts for the immense attrition rate of research products from pharmaceutical research and development to clinical studies, and the initial setbacks of gene therapy when performed in humans[1], although some success has been seen more recently in gene therapy for selected diseases, for example, Parkinson's disease or lymphoid immunodeficiencies[2,3]. In line with N2B (Bench-to-Bedside) translational medicine philosophy, the search continues for a modeling system that operates in a way that resembles the human body as closely as possible, hence the advent of using perfused
human organs. As exemplified by the Ex Vivo Metrics©[4], a human organ can be harvested and revitalized with matched blood in a control-simulated environment. The trial drug would be given via appropriate routes, and subsequent biochemical analysis would be performed, amongst other physiological endpoints.
Discussion Theoretical advantages of perfused human organs Ex vivo human organs allow
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