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

Perić, Mihaela and Dumić-Čule, Ivo and Grčević, Danka and Matijašić, Mario and Verbanac, Donatella and Paul, Ruth and Grgurević, Lovorka and Trkulja, Vladimir and Bagi, Čedo M. and Vukičević, Slobodan (2015) The rational use of animal models in the evaluation of novel bone regenerative therapies. Bone, 70. pp. 73-86. ISSN 8756-3282

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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".

Item Type: Article
Additional Information: Copyright © 2014 Elsevier Inc. All rights reserved.
MeSH: Animals ; Biocompatible Materials/pharmacology ; Bone Regeneration/drug effects ; Disease Models, Animal ; Humans ; Regenerative Medicine/methods ; Statistics as Topic ; Wound Healing/drug effects
Departments: Katedra za anatomiju i kliničku anatomiju
Katedra za farmakologiju
Depositing User: Marijan Šember
Status: Published
Creators:
CreatorsEmail
Perić, MihaelaUNSPECIFIED
Dumić-Čule, IvoUNSPECIFIED
Grčević, DankaUNSPECIFIED
Matijašić, MarioUNSPECIFIED
Verbanac, DonatellaUNSPECIFIED
Paul, RuthUNSPECIFIED
Grgurević, LovorkaUNSPECIFIED
Trkulja, VladimirUNSPECIFIED
Bagi, Čedo M.UNSPECIFIED
Vukičević, SlobodanUNSPECIFIED
Date: January 2015
Date Deposited: 27 Oct 2015 13:02
Last Modified: 27 Oct 2015 13:02
Subjects: /
Related URLs:
URI: http://medlib.mef.hr/id/eprint/2330

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