Open AccessCurrent standards and ethical landscape of engineered tissues—3D bioprinting perspective
Author(s) -
Muthu Parkkavi Sekar,
Harshavardhan Budharaju,
Allen Zennifer,
Swaminathan Sethuraman,
Niki Vermeulen,
Dhakshinamoorthy Sundaramurthi,
Deepak M. Kalaskar
Publication year - 2021
Publication title -
journal of tissue engineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.436
H-Index - 30
ISSN - 2041-7314
DOI - 10.1177/20417314211027677
Subject(s) - 3d bioprinting , commercialization , engineering ethics , risk analysis (engineering) , tissue engineering , engineering management , nanotechnology , medicine , computer science , microbiology and biotechnology , engineering , biomedical engineering , business , biology , materials science , marketing
Tissue engineering is an evolving multi-disciplinary field with cutting-edge technologies and innovative scientific perceptions that promise functional regeneration of damaged tissues/organs. Tissue engineered medical products (TEMPs) are biomaterial-cell products or a cell-drug combination which is injected, implanted or topically applied in the course of a therapeutic or diagnostic procedure. Current tissue engineering strategies aim at 3D printing/bioprinting that uses cells and polymers to construct living tissues/organs in a layer-by-layer fashion with high 3D precision. However, unlike conventional drugs or therapeutics, TEMPs and 3D bioprinted tissues are novel therapeutics and need different regulatory protocols for clinical trials and commercialization processes. Therefore, it is essential to understand the complexity of raw materials, cellular components, and manufacturing procedures to establish standards that can help to translate these products from bench to bedside. These complexities are reflected in the regulations and standards that are globally in practice to prevent any compromise or undue risks to patients. This review comprehensively describes the current legislations, standards for TEMPs with a special emphasis on 3D bioprinted tissues. Based on these overviews, challenges in the clinical translation of TEMPs & 3D bioprinted tissues/organs along with their ethical concerns and future perspectives are discussed.