Clinical testing and development of novel therapies based on advances in tissue engineering and regenerative medicine that will one day enable the repair and replacement of diseased or damaged human muscle, bone, tendons, and ligaments depends on the availability of good animal models. The highlights of a recent workshop that explored the need for and current status of animal models for musculoskeletal regenerative medicine are presented in a special issue of Tissue Engineering, Part B: Reviews, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com) The issue is available free online (www.liebertpub.com/ten).
The production of specially engineered tissues to restore the function and viability of cartilage or meniscus in the knee, for example, or of degenerating intervertebral discs in the spine, will likely one day be commonplace. In the meantime, however, there is substantial need for better and standardized animal models for the development and testing of these innovative techniques. At the National Institutes of Health (NIH)-sponsored workshop "Translational Models for Musculoskeletal Tissue Engineering and Regenerative Medicine," leaders in the field described available models, outlined the unmet needs, and discussed the translational pathways for clinical testing and therapeutic use.
Mark Lee, PhD, and colleagues from the U.S. Food and Drug Administration (FDA, Rockville, MD) explained how the complexity of engineered tissue constructs, often containing a combination of cells, scaffolds, and other factors, creates challenges for product characterization and manufacturing. In their paper "Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States," they provide resources and recommendations to help product developers optimize the safety and effectiveness of engineered tissues ready for testing in clinical trials.