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Bone. 2015 Jan;70:73-86. doi: 10.1016/j.bone.2014.07.010. Epub 2014 Jul 13.

The rational use of animal models in the evaluation of novel bone regenerative therapies.

Author information

1
University of Zagreb School of Medicine, Center for Translational and Clinical Research, Department for Intercellular Communication, Salata 2, Zagreb, Croatia. Electronic address: mihaela.peric@mef.hr.
2
University of Zagreb School of Medicine, Center for Translational and Clinical Research, Laboratory for Mineralized Tissues, Salata 11, Zagreb, Croatia.
3
University of Zagreb School of Medicine, Department of Physiology and Immunology, Salata 3, Zagreb, Croatia.
4
University of Zagreb School of Medicine, Center for Translational and Clinical Research, Department for Intercellular Communication, Salata 2, Zagreb, Croatia.
5
Paul Regulatory Services Ltd, Fisher Hill Way, Cardiff CF15 8DR, UK.
6
University of Zagreb School of Medicine, Department of Pharmacology, Salata 11, Zagreb, Croatia.
7
Pfizer Inc., Global Research and Development, Global Science and Technology, 100 Eastern Point Road, Groton, CT 06340, USA.
8
University of Zagreb School of Medicine, Center for Translational and Clinical Research, Laboratory for Mineralized Tissues, Salata 11, Zagreb, Croatia. Electronic address: vukicev@mef.hr.

Abstract

Bone has a high potential for endogenous self-repair. However, due to population aging, human diseases with impaired bone regeneration are on the rise. Current strategies to facilitate bone healing include various biomolecules, cellular therapies, biomaterials and different combinations of these. Animal models for testing novel regenerative therapies remain the gold standard in pre-clinical phases of drug discovery and development. Despite improvements in animal experimentation, excessive poorly designed animal studies with inappropriate endpoints and inaccurate conclusions are being conducted. In this review, we discuss animal models, procedures, methods and technologies used in bone repair studies with the aim to assist investigators in planning and performing scientifically sound experiments that respect the wellbeing of animals. In the process of designing an animal study for bone repair investigators should consider: skeletal characteristics of the selected animal species; a suitable animal model that mimics the intended clinical indication; an appropriate assessment plan with validated methods, markers, timing, endpoints and scoring systems; relevant dosing and statistically pre-justified sample sizes and evaluation methods; synchronization of the study with regulatory requirements and additional evaluations specific to cell-based approaches. This article is part of a Special Issue entitled "Stem Cells and Bone".

KEYWORDS:

Animal model; Bone fracture; Bone healing; Healing parameters; Regenerative therapy; Tools for scoring

PMID:
25029375
DOI:
10.1016/j.bone.2014.07.010
[Indexed for MEDLINE]

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