Tissue Engineered Constructs: Perspectives on Clinical Translation
Tóm tắt
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.
Tài liệu tham khảo
Bayon, Y., A. A. Vertès, V. Ronfard, M. Egloff, S. Snykers, G. Franco Franco Salinas, R. Thomas, A. Girling, R. Lilford, G. Clermont, and P. Kemp. Translating cell-based regenerative medicines from research to successful products: challenges and solutions. Tissue Eng. Part B 20(4):246–256, 2014.
Bertram, T. A., E. Tentoff, P. Johnson, B. Tawil, M. Van Dyke, and K. B. Hellman. Hurdles in tissue engineering/regenerative medicine product commercialization: a pilot survey of governmental funding agencies and the financial industry. Tissue Eng. Part A 18:2187–2194, 2012.
Bertram, T., K. B. Hellman, Y. Bayon, S. Ellison, and S. Wilburn. The regulatory imperative: international perspective. Tissue Eng. Part B 19:191–193, 2013.
de Vries, R. B., A. Oerlemans, L. Trommelmans, K. Dierickx, and B. Gordijn. Ethical aspects of tissue engineering: a review. Tissue Eng. Part B 14:367–375, 2008.
Harrison, R. H., J. P. St-Pierre, and M. M. Stevens. Tissue engineering and regenerative medicine: a year in review. Tissue Eng. Part B 20:1–16, 2014.
Hellman, K. B., P. C. Johnson, T. A. Bertram, and B. Tawil. Challenges in tissue engineering and regenerative medicine product commercialization: building an industry. Tissue Eng. Part A 17:1–3, 2011.
Hollister, S. J., and W. L. Murphy. Scaffold translation: barriers between concept and clinic. Tissue Eng. Part B 17:459–474, 2011.
Lee, M. H., J. A. Arcidiacono, A. M. Bilek, J. J. Wille, C. A. Hamill, K. M. Wonnacott, M. A. Wells, and S. S. Oh. Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States. Tissue Eng. Part B 16:41–54, 2010.
Minger, S. Interspecies SCNT-derived human embryos–a new way forward for regenerative medicine. Regen. Med. 2:103–106, 2007.
Moore, C. G. Killing the Bayh-Dole Act’s Golden Goose. Tulane J. Technol. Intellect. Property 151:153–154, 2006.
National Patient Safety Foundation. Quality, Safety and Reliability: Engaging Physicians and Influencing Culture Change, webcast July 27, 2011.
Oerlemans, A. J., P. P. van den Berg, E. van Leeuwen, and W. J. Dekkers. Ethical issues regarding the donation and source of cells for tissue engineering: a European focus group study. Tissue Eng. Part B 17:229–234, 2011.
Pashuck, E. T., and M. M. Stevens. Designing regenerative biomaterial therapies for the clinic. Sci. Transl. Med. 4(160):1–12, 2012.
Shapiro, J. K., B. J. Wesoloski. FDA’s Regulatory Scheme for Human Tissue. A Brief Overview. FDLI Update, Nov/Dec, 2007.
Smith, D. S. The government’s role in advancing regenerative medicine and tissue engineering—science, safety, and ethics. Periodontol 2000(41):16–29, 2006.
Taylor, D. A., A. L. Caplan, and P. Macchiarini. Ethics of bioengineering organs and tissues. Expert Opin. Biol. Ther. 14:879–882, 2014.