Improving the Rate of Translation of Tissue Engineering Products

Abstract

also need to occur in order to ensure that the engineered tissues faithfully recapitulate the in vivo tissue microenvironment and exhibit appropriate mechanical properties. [15][16][17][18][19][20][21][22][23] The community also needs to minimize the gap between current understanding of tissue remodeling and cellular behavior in vivo [24][25][26][27][28] and how this knowledge is applied to improve the performance and reliability of TE products. Technologies also need to be developed to effectively preserve manufactured tissues and achieve consistent manufacturing outcomes. [29][30][31][32][33][34][35][36][37] Moreover, the inherent complexity of TE products has significantly muddied the regulatory process for these products, and companies and regulators often do not know which regulatory pathways would be applicable. For Tissue Engineering

Cells, Materials, and Fabrication Processes for Cardiac Tissue Engineering

“…-How is translation going to happen? The hurdles are significant, (Desgres and Menasché, 2019;Ghaemi et al, 2019) not only due to the use of genetically modified cells (hiPSCs), exogenous materials and complex equipment, but also because in order to attain sufficient functional capacity, it is likely that some lengthy period of in vitro electromechanical maturation must be implemented. Also, no standard equipment currently exists to apply this to a human-scale tissue.…”

“…In stark contrast to the short time elapsing between the first reports on regenerative medicine with adult stem cells and their first in-human application (reviewed in Banerjee et al, 2018 ) cTE with hPSCs has scarcely reached the clinical arena. Be it because both scientists and clinicians have learnt from past experiences or because translation presents additional complications, ( Desgres and Menasché, 2019 ; Ghaemi et al, 2019 ; Ke and Murphy, 2019 ) clinical application is yet to become a reality. The technology faces challenges in the area of regulation, where reprogrammed cells under GMP-conditions are not widely derived, in logistics, with the size of engineered tissues in most instances requiring open chest surgery, and in economic terms.…”

The Role of Machine Learning and Design of Experiments in the Advancement of Biomaterial and Tissue Engineering Research

“…New methods have been developed that include the direct injection of cells to the affected area, reducing surgical invasiveness and its associated risks [ 2 ]. Despite its relatively short history (i.e., 40 years) [ 3 ], TE has become a fertile ground for scientific discoveries in both applied and fundamental sciences. There has been a tremendous expansion in the field since its initial goal—to address the shortage of tissue and organ donors by creating replacement tissues, such as cartilage, blood vessels, bone, and skin.…”

Neovascularization of engineered tissues for clinical translation: Where we are, where we should be?

“…Regenerative medicine aims to circumvent issues associated with organ transplants such as graft-vs-host disease (GvHD) and organ shortage. 3 Several avascular tissues, such as cartilage, bladder, and skin, have already been constructed successfully and been used in clinics. 4–6 Unfortunately, tissue engineering strategies for larger vascularized organs and thick tissues have thus far proven limited, due to the lack of standardized protocols for generating a robust microvascular network with a mean diffusion distance of 150–200 μ m, a critical diffusion limit.…”