title: New Phase of Growth for Xenogeneic-Based Bioartificial Organs.
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.
authors.affiliation: Organogenesis Inc., 150 Dan Road, Canton, MA 02021, USA. zpitkin@organo.com.
authors.forename: Zorina
authors.initials: Z
authors.lastname: Pitkin
keywords: bioartificial organs; clinical trials; gene editing; risk assessment; xenotransplantation