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SAGE Publications, Journal of Cerebral Blood Flow and Metabolism, 1(29), p. 1-9, 2008

DOI: 10.1038/jcbfm.2008.98

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The role of animal models in evaluating reasonable safety and efficacy for human trials of cell-based interventions for neurologic conditions.

Journal article published in 2008 by Alan Regenberg, Debra Jh H. Mathews, David M. Blass, Hilary Bok, Joseph T. Coyle, Patrick Duggan, Ruth Faden, Julia Finkel, John D. Gearhart, Argye Hillis, Ahmet Hoke, Richard Johnson, Michael Johnston, Jeffrey Kahn ORCID, Douglas Kerr and other authors.
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Progress in regenerative medicine seems likely to produce new treatments for neurologic conditions that use human cells as therapeutic agents; at least one trial for such an intervention is already under way. The development of cell-based interventions for neurologic conditions (CBI-NCs) will likely include preclinical studies using animals as models for humans with conditions of interest. This paper explores predictive validity challenges and the proper role for animal models in developing CBI-NCs. In spite of limitations, animal models are and will remain an essential tool for gathering data in advance of first-in-human clinical trials. The goal of this paper is to provide a realistic lens for viewing the role of animal models in the context of CBI-NCs and to provide recommendations for moving forward through this challenging terrain.Keywords: clinical trials, modeling, neurologic conditions, stem and progenitor cells