ABSTRACT

The objective of musculoskeletal tissue engineering is to facilitate and improve patient outcomes with concomitant reduction in morbidity, complication, and expense. Researchers can maximize preclinical animalmodel predictive value by testing in multiple mammalian species, lowering the risk of new tissue engineering approaches. A strong understanding and knowledge of the intended clinical goal will inform preclinical design, scientifically rigorous methods, product parameters, and clarify regulatory-pathway strategies. AOVET, the veterinary specialty group of the AO Foundation, the AO Research Institute, and the European Academy

CONTENTS

12.1 Introduction ................................................................................................ 205 12.1.1 Opportunity and Need Do Not Predict Success ....................... 206 12.1.2 Challenges to Industry and Academia ....................................... 207

12.2 Translational Research .............................................................................. 208 12.3 General Guidelines for In Vivo Animal Experiments .......................... 210

12.3.1 Questions Basic to Tissue Engineering ....................................... 211 12.3.2 Impaired or Compromised Healing ........................................... 212

12.4 Adaptive Application of Established and New Animal Models ........ 212 12.4.1 Craniofacial Models ....................................................................... 212 12.4.2 Long-Bone Models ......................................................................... 213 12.4.3 Musculoskeletal Infection ............................................................ 214 12.4.4 Cartilage Repair and Osteoarthritis ........................................... 217 12.4.5 Spine ................................................................................................ 220

12.5 Cell-Based Tissue Engineering ................................................................ 221 12.5.1 Gene Therapy ................................................................................. 221 12.5.2 Stem Cells ........................................................................................222

12.6 Summary ..................................................................................................... 224 References .............................................................................................................225

for the Study of Scientific and Technological Advance, have sought to establish standards and guidelines on the use and design of musculoskeletal animal-research models (see Auer et al., 2007) with the overall goal of enhanced outcome performance. “It is better not to do the experiment than to do it using the wrong model” (Alini et al., 2008).