The U.S. Food and Drug Administration (FDA) advisors are discussing development, regulations, and ethical considerations of using artificial womb technology (AWT) in humans.
The Pediatric Advisory Committee (PAC) discussions that are being held on September 19 and 20 are limited to the use of AWT as an alternative to the current standard-of-care management of extremely premature infants in the Neonatal Intensive Care Unit (NICU).
The meeting is convened as the Children’s Hospital of Philadelphia (CHOP) researchers seek approval for their artificial womb device, the Extra-uterine Environment for Newborn Development, or EXTEND, to be tested in human clinical trials.
In 2017, the CHOP researchers published the findings of the preclinical studies in which they tested and monitored EXTEND effects on fetal lambs, physiologically equivalent to a 23- or 24-week-gestation human infant. Prenatal lung development in lambs is very similar to that occurring in humans.
The lamb fetuses had been transferred from the maternal womb to the device that mimicked the prenatal fluid-filled environment, in which they developed and stayed alive for 28 days.
They grew in a temperature-controlled, near-sterile environment, breathing amniotic fluid while their hearts pumped blood through their umbilical cord into a gas exchange machine outside the bag.
The researchers then said that the system could prevent the severe morbidity of extremely premature infants by giving them a few weeks to develop their lungs and other organs.
Simultaneously, the University of Michigan researchers created an out-of-body “artificial placenta” mimicking the womb, where lambs lived up to 16 days while developing lung function and the brain.
However, not all attempts were successful. The Artificial womb EVE Therapy developed by Australian researchers resulted in some brain injury due to a technical issue.
Ethical questions remain unanswered
As the artificial womb technology develops, scientists debate legal and ethical challenges that may arise. For instance, it remains unclear how legal systems would integrate a new method of gestation “into the scope of existing assisted reproductive biotechnologies,” according to a 2022 paper.
Additionally, there are concerns about safety for pregnant women and that the technology may cause unforeseen damage to developing fetuses. Some fear that artificial wombs could be used to further restrict women’s reproductive liberty and access to abortion.
Meanwhile, preterm birth — when a baby is born too early, before 37 weeks of pregnancy — is a growing health problem in the U.S. The premature rates increased from 10.1% of all babies born in 2020 to 10.5% in 2021, disproportionately affecting African-American women.
Premature babies, especially those born before 32 weeks, have higher death rates. In 2020, preterm birth and low birth weight accounted for about 16% of infant deaths. Those who survive are at risk of breathing problems, feeding difficulties, cerebral palsy, developmental delay, and vision and hearing problems.
The FDA advisors are only discussing the possibility of using the artificial womb technology in human clinical trials, meaning that it may take years until the technology can be widely applied.
- U.S. Food and Drug Administration. Pediatric Advisory Committee Meeting Announcement.
- Philadelphia Children's Hospital. A Unique Womb-Like Device Could Reduce Mortality and Disability for Extremely Premature Babies.
- Nature Communications. An extra-uterine system to physiologically support the extreme premature lamb.
- Centers for Disease Control and Prevention. Preterm Birth.
- The University of Michigan. Animal Model, ECMO Technology Used to Help Develop Innovative Artificial Placenta.