Federal regulators are currently engaged in discussions surrounding artificial wombs, which are seen as a crucial step towards conducting clinical trials on humans. The FDA advisers are convening this week to discuss the technology behind artificial wombs and artificial placenta. It is important to note that these devices would not replace the need for a human womb, but rather serve as a bridge for extremely premature babies, referred to as “neonates,” as they grow and develop after birth.

Videos shared by researchers from the University of Michigan and Children’s Hospital of Philadelphia have provided a glimpse into the appearance and functionality of these artificial wombs. They typically involve a bag containing synthetic amniotic fluid, along with tubes connected to the umbilical cord. These devices facilitate the removal of harmful carbon dioxide from the blood, while ensuring the delivery of oxygen and nutrients.

Over the course of the past six years, researchers have observed positive outcomes in terms of brain, lung, and gut development in preterm lambs and fetal pigs using artificial wombs. Dr. Alan Flake, the director at the center for fetal research at the Children’s Hospital of Philadelphia, stated that they have successfully transitioned pig fetuses, with human size, from placental support to circuit support with physiological blood flows.

At the FDA advisers’ meeting, potential guidelines for the initial studies involving the transition from preterm animals to humans will be discussed. Several important questions will be addressed, such as the logistics of moving a patient to an artificial womb, the criteria for qualifying a patient for artificial womb treatment, and the ethical considerations in designing the first studies.

Preterm births, which are defined as those occurring at 37 weeks or earlier, are a significant concern. Cases occurring at 32 weeks or earlier are categorized as extremely premature. Data from the CDC reveals that 1 in 10 babies born in the U.S. are premature, and a staggering 65% of all infant deaths are of premature babies.

While the discussions surrounding artificial wombs are promising, it is important to note that it will still be several months, if not years, before any clinical trials involving humans are conducted. Additionally, individual research hospitals will need to conduct their own ethics and science reviews before human testing can take place.