TY - JOUR
T1 - Tissue Engineered Constructs
T2 - Perspectives on Clinical Translation
AU - Lu, Lichun
AU - Arbit, Harvey M.
AU - Herrick, James L.
AU - Segovis, Suzanne Glass
AU - Maran, Avudaiappan
AU - Yaszemski, Michael J.
N1 - Publisher Copyright:
© 2015, Biomedical Engineering Society.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - 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.
AB - 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.
KW - Bioethics
KW - Commercialization
KW - Food and Drug Administration (FDA)
KW - Medical devices
KW - Regulatory issues
KW - Tissue engineered medical products (TEMPs)
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U2 - 10.1007/s10439-015-1280-0
DO - 10.1007/s10439-015-1280-0
M3 - Article
C2 - 25711151
AN - SCOPUS:84939954699
SN - 0090-6964
VL - 43
SP - 796
EP - 804
JO - Annals of Biomedical Engineering
JF - Annals of Biomedical Engineering
IS - 3
ER -