Abstract
In this article, we examine the advanced clinical development of bioartificial organs and describe the challenges to implementing such systems into patient care. The case for bioartificial organs is evident: they are meant to reduce patient morbidity and mortality caused by the persistent shortage of organs available for allotransplantation. The widespread introduction and adoption of bioengineered organs, incorporating cells and tissues derived from either human or animal sources, would help address this shortage. Despite the decades of development, the variety of organs studied and bioengineered, and continuous progress in the field, only two bioengineered systems are currently commercially available: Apligraf® and Dermagraft® are both approved by the FDA to treat diabetic foot ulcers, and Apligraf® is approved to treat venous leg ulcers. Currently, no products based on xenotransplantation have been approved by the FDA. Risk factors include immunological barriers and the potential infectivity of porcine endogenous retrovirus (PERV), which is unique to xenotransplantation. Recent breakthroughs in gene editing may, however, mitigate risks related to PERV. Because of its primary role in interrupting progress in xenotransplantation, we present a risk assessment for PERV infection, and conclude that the formerly high risk has been reduced to a moderate level. Advances in gene editing, and more broadly in the field, may make it more likely than ever before that bioartificial organs will alleviate the suffering of patients with organ failure.
Highlights
Since the 1960s, researchers have been developing bioartificial alternatives to allotransplantation
Clinical case studies were reported in 160 patients, 55 of whom received bioartificial organs made from autologous cells that were seeded on scaffolds of various origins [2,8]
Since pigs are considered the species of choice in xenotransplantation, we will briefly review the risks associated with the use of bioartificial organs sourced from pig organs/tissues
Summary
Since the 1960s, researchers have been developing bioartificial alternatives to allotransplantation. Sci. 201fu6n, c1t7io, n1s59o3f the failing organ This is achieved by integrating a biological component (human or nonhuman cells and tissues) with synthetic or natural platforms. For reaso2n.sBiwoaertiwficilal Orergvaineswo,nmtheoMstarbkieot engineered tissues still remain far from commercialization. Several comprehensive reviews have been published on bioartificial organs currently in development. They span systems utilizing autologous cells [2,8,9], bioartificial systems at the stage of pre-clinical investigations [10,11], and clinical case reports. This paper will summarize them briefly, and focus on bioartificial organs that have either been approved for clinical investigation or have already been tested in clinical trials. As an illustrative case study, we will offer a risk assessment of potential infectivity of porcine endogenous retrovirus (PERV)
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