First-in-Human Studies of Artificial Wombs Subject of FDA’s Adcomm This Week

September 20, 2023

The best way to design trials around an artificial womb intended to better regulate body temperature and foster safer lung development in extremely premature infants (EPI) is the focus of the FDA’s Pediatric Advisory Committee as they meet on Tuesday and Wednesday of this week.

The panel plans to discuss the development plans for establishing safety and effectiveness of artificial womb technology (AWT) devices, including regulatory and ethical considerations for first in human studies, said the FDA in its briefing documents for the meeting.

AWT is a proposed therapeutic strategy that aims to bridge the period between extreme preterm birth and later gestation to allow for organ maturation in a system that mimics the womb environment. The system includes an extrauterine environment comprised of a simulated womb with artificial amniotic fluid and an artificial placenta that provides circulation and oxygenation for medication and nutrient delivery, as well as gas exchange.

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