Milestones for clinical translation of the artificial placenta

Despite significant advances in the treatment of prematurity, premature birth results in significant mortality and morbidity. In particular, extremely low gestational age newborns (ELGANs) defined as <28 weeks estimated gestational age (EGA) suffer from disproportionate mortality and morbidity. A radical paradigm shift in the treatment of prematurity is to recreate fetal physiology using an extracorporeal VV-ECLS artificial placenta (AP) or an AV-ECLS artificial womb (AW). Over the past 15 years, tremendous advances have been made in the laboratory confirming long-term support and organ protection and ongoing development. The major milestones to clinical application are miniaturization, anticoagulation, clinical risk stratification, specialized critical care protocols, a regulatory path and a strategy and platform to translate technology to the bedside. Currently, several groups are addressing the remaining milestones for clinical translation.