In this article, a “bedside to bench and back” approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.
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Biomaterials and Tissue Engineering Laboratory, Departments of Orthopedic Surgery and Biomedical Engineering, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN, 55905, USA
Lichun Lu, James L. Herrick, Suzanne Glass Segovis, Avudaiappan Maran & Michael J. Yaszemski
Arbit Consulting, LLC, 1782 Trail Road, Saint Paul, MN, 55118-3730, USA
Harvey M. Arbit
Correspondence to Lichun Lu.
Additional informationAssociate Editor Fei Wang oversaw the review of this article.
About this article Cite this articleLu, L., Arbit, H.M., Herrick, J.L. et al. Tissue Engineered Constructs: Perspectives on Clinical Translation. Ann Biomed Eng 43, 796–804 (2015). https://doi.org/10.1007/s10439-015-1280-0
Received: 04 August 2014
Accepted: 11 February 2015
Published: 25 February 2015
Issue Date: March 2015
DOI: https://doi.org/10.1007/s10439-015-1280-0
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