FDA Meeting This Week to Discuss Advancements in Artificial Womb Technology

Federal regulators are currently discussing the potential use of artificial wombs as a crucial step towards conducting the first clinical trials for humans. This week, FDA advisers will be meeting to further explore artificial womb and artificial placenta technology. It is important to note that the device would not replace a human womb, but rather act as a bridge for extremely premature babies or “neonates” as they are born and continue to grow. Researchers from the University of Michigan and Children’s Hospital of Philadelphia have shared videos demonstrating the appearance and functionality of the technology. The artificial wombs include a bag filled with synthetic amniotic fluid and tubes that are connected to the umbilical cord. These tubes remove harmful carbon dioxide from the blood and provide oxygen and nutrients. Promisingly, studies on preterm lambs and fetal pigs over the past six years have shown enhanced brain, lung, and gut development. However, many questions still need to be addressed in these upcoming discussions, such as how patients would be transferred to an artificial womb, what criteria would qualify a patient for this treatment, and the ethical considerations for designing the initial studies. Preterm births, which are defined as births occurring at 37 weeks or earlier, make up a significant portion of U.S. births, with 1 in 10 babies being born prematurely. Moreover, premature babies account for 65% of all infant deaths. It is important to note that the clinical trials in humans are still months or even years away, as individual research hospitals will need to undergo their own ethical and scientific reviews before initiating any human tests.