Ethical, Translational, and Legal Issues Surrounding the Novel Adoption of Ectogestative Technologies

Abstract

Increasing numbers of research teams are investigating the feasibility of developing artificial amnion and placenta technology (AAPT), commonly referred to as "artificial womb technology". This technology, aimed at supporting ex vivo gestation, has not yet been tested in humans, but it has been stated that we are closer to clinical application than ever before as breakthroughs in animal studies demonstrate good proof of principle. With these proof-of-concept models, further dissemination of AAPT as a research modality is expected. In this review article, we consider the ethical implications of the most imminent anticipated applications for AAPT. We focus specifically on the specific ethical complications regarding the improvements this technology may offer to conventional neonatal intensive care, its potential utility in facilitating prenatal interventions, and some of the broader socio-legal implications such as the debates about abortion access and reproductive and gestational choices. We discuss translational and societal questions when it comes to designing and developing this technology, like commitments to value-sensitive design, along with an examination of the legal and moral status of the entity gestating ex utero, which will be relevant for how it ought to be treated in the context of these various applications. From these perspectives, this review identifies the ethical questions that we believe to be most pressing in the development and potential introduction of AAPT, with due attention to their manifestation as translational and legal issues.

Ectogenesis: understanding opportunities, implications, concerns, and ways forward

“…Experts and stakeholders should work together to address technological, moral, and societal issues in order to advance this artificial womb technology. Priorities include the creation of clear ethical frameworks, ongoing technology innovation to replicate the womb's environment, and multidisciplinary research to close physiological gaps between humans and animals [9] . These recommendations support thorough preclinical research, processes for obtaining informed permission, and a methodical approach to clinical introduction.…”

“…Understanding this concept of ectogenesis will advance modern medical practices by enhancing scientific understanding of embryonic development and its applications in regenerative medicine [8] . This study can help address ethical concerns about how human life begins and reproductive options while promoting reproductive equality through alternatives to traditional pregnancy [9] . This paper discusses ectogenesis, or the artificial womb, and provides an analysis to contribute to global discussion and debate.…”

Artificial placentas, pregnancy loss and loss-sensitive care

“…Preterm birth is associated with high neonatal morbidity and mortality. 4 Some entities are born too physiologically immature to survive in the external environment and there are innate risks to NICU interventions including lung damage, infection and heart failure. 41 Researchers have, therefore, sought to develop new technologies that embody a paradigmatic shift to care of entities delivered extremely premature: rather than trying to facilitate incubation of extreme premature neonates, researchers are attempting to develop technology that can facilitate gestation outside of the body.…”

“…Romanis has suggested the term 'gestateling' 3 which could better manage parental expectationsthe entity is not in a state, like babies in NICU often are-where it can be held, touched, smelled. 4 Using a unique term might also help give parents an understanding of the ambiguity gap that results when the ending of a pregnancy and the entity entering the world postgestation do not coincide. Moreover, this unique term does not map onto our existing language in a way that might lead to pregnant people trying to shoehorn their experience of AAPT into the language and ideas we already have.…”

“…Partial ectogestation-the use of Artificial Amnion and Placenta Technology (AAPT) 2 to 'take over' gestation where a pregnancy ends prematurely 3 -is an increasingly imminent prospect. 4 Researchers in Philadelphia are anticipating that clinical testing on human preterm neonates will begin in 2024. 5 AAPT has the potential to revolutionise our approach to treating prematurity, 3 which is the leading cause of neonatal deaths across the globe.…”