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Fabrication of Myogenic Engineered Tissue Constructs
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Tissue engineered constructs: perspectives on clinical translation.

Lichun Lu1, Harvey M Arbit, James L Herrick

  • 1Biomaterials and Tissue Engineering Laboratory, Departments of Orthopedic Surgery and Biomedical Engineering, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN, 55905, USA, Lu.lichun@mayo.edu.

Annals of Biomedical Engineering
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Summary

Developing tissue engineered medical products (TEMPs) requires a "bedside to bench and back" strategy, addressing clinical needs, preclinical research, ethical, regulatory, and commercialization challenges for successful clinical translation.

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Area of Science:

  • Biomedical Engineering
  • Regenerative Medicine
  • Translational Science

Background:

  • Unmet clinical needs drive the development of tissue engineered medical products (TEMPs).
  • A bidirectional "bedside to bench and back" approach is crucial for translating TEMPs into clinical practice.
  • Ethical, regulatory, and commercialization hurdles must be overcome for successful TEMP development.

Purpose of the Study:

  • To review the comprehensive "bedside to bench and back" approach for developing TEMPs.
  • To highlight key considerations in preclinical and clinical research for TEMPs.
  • To outline the regulatory pathways and commercialization strategies for TEMPs.

Main Methods:

  • Review of the "bedside to bench and back" methodology for TEMPs.
  • Discussion of preclinical research (in vitro and in vivo models).
  • Analysis of clinical research, ethical considerations, and regulatory pathways (FDA regulations for drugs, biologics, devices, combination products).
  • Case study on nerve cuffs to illustrate the regulatory process.
  • Exploration of commercialization aspects, including partnerships and funding.

Main Results:

  • The "bedside to bench and back" approach integrates clinical needs with scientific research.
  • Preclinical studies address key research questions using animal models.
  • Ethical and regulatory compliance are paramount for clinical translation.
  • The FDA employs various regulatory pathways (e.g., 510(k), BLA, NDA) for TEMPs.
  • Commercialization requires strategic planning for partnerships and funding.

Conclusions:

  • Successful clinical application of TEMPs necessitates a multidisciplinary approach.
  • Addressing ethical, regulatory, and commercialization factors is essential for advancing TEMPs.
  • The "bedside to bench and back" model provides a framework for navigating the complexities of TEMP development and translation.