Tissue Engineered Constructs: Perspectives on Clinical Translation

Lichun Lu, Harvey M. Arbit, James L. Herrick, Suzanne Glass Segovis, Avudaiappan Maran, Michael J Yaszemski

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)796-804
Number of pages9
JournalAnnals of Biomedical Engineering
Volume43
Issue number3
DOIs
StatePublished - Mar 1 2015

Fingerprint

Tissue
Animals
Industry

Keywords

  • Bioethics
  • Commercialization
  • Food and Drug Administration (FDA)
  • Medical devices
  • Regulatory issues
  • Tissue engineered medical products (TEMPs)

ASJC Scopus subject areas

  • Biomedical Engineering

Cite this

Tissue Engineered Constructs : Perspectives on Clinical Translation. / Lu, Lichun; Arbit, Harvey M.; Herrick, James L.; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J.

In: Annals of Biomedical Engineering, Vol. 43, No. 3, 01.03.2015, p. 796-804.

Research output: Contribution to journalArticle

Lu, Lichun ; Arbit, Harvey M. ; Herrick, James L. ; Segovis, Suzanne Glass ; Maran, Avudaiappan ; Yaszemski, Michael J. / Tissue Engineered Constructs : Perspectives on Clinical Translation. In: Annals of Biomedical Engineering. 2015 ; Vol. 43, No. 3. pp. 796-804.
@article{a2a16c0739ea43468b220c62a0800e4f,
title = "Tissue Engineered Constructs: Perspectives on Clinical Translation",
abstract = "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.",
keywords = "Bioethics, Commercialization, Food and Drug Administration (FDA), Medical devices, Regulatory issues, Tissue engineered medical products (TEMPs)",
author = "Lichun Lu and Arbit, {Harvey M.} and Herrick, {James L.} and Segovis, {Suzanne Glass} and Avudaiappan Maran and Yaszemski, {Michael J}",
year = "2015",
month = "3",
day = "1",
doi = "10.1007/s10439-015-1280-0",
language = "English (US)",
volume = "43",
pages = "796--804",
journal = "Annals of Biomedical Engineering",
issn = "0090-6964",
publisher = "Springer Netherlands",
number = "3",

}

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

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)

UR - http://www.scopus.com/inward/record.url?scp=84939954699&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84939954699&partnerID=8YFLogxK

U2 - 10.1007/s10439-015-1280-0

DO - 10.1007/s10439-015-1280-0

M3 - Article

C2 - 25711151

AN - SCOPUS:84939954699

VL - 43

SP - 796

EP - 804

JO - Annals of Biomedical Engineering

JF - Annals of Biomedical Engineering

SN - 0090-6964

IS - 3

ER -