Independent advisers to the US Food and Drug Administration will meet Tuesday and Wednesday to discuss the regulations, ethics and possibilities of creating an artificial womb to increase the chances that extremely premature babies would survive — and without long-term health problems.
Although no such device has been tested in humans, similar ones have been used in a handful of cases to successfully develop animals. Advisers will consider what human trials could look like.
An artificial womb for humans would be a scientific advance that could help solve a major health problem. Preterm births are the No. 1 killer of children under the age of 5, according to the World Health Organization.
Because a baby’s lungs and brain finish developing late in pregnancy, a child born prematurely risks a lifetime of health problems including trouble breathing, gastrointestinal issues, vision and hearing problems, developmental delays and cerebral palsy.
Prematurity has become a growing problem in the US. The number of preterm births increased from 10.1% of all babies born in 2020 to 10.5% in 2021, according to the US Centers for Disease Control and Prevention. The issue disproportionately affects African Americans, who give birth prematurely at a rate that is 50% higher than those of White and Hispanic people.
An artificial womb is not designed to replace a pregnant person; it could not be used from conception until birth. Rather, it could be used to help a small number of infants born before 28 weeks of pregnancy, which is considered extreme prematurity. Less than 1% of babies are born this early.
The earlier an infant is born, the greater the risk of death. For example, only about 30% of infants born at 22 weeks survive, and just under 56% survive birth at 23 weeks, according to a 2022 study published in the journal JAMA.
The artificial womb could be able to help the baby develop further through those vital final stages when the lung and brain are developing. Like a person’s womb, it would deliver oxygen, nutrients and hormones.
Premature babies have to stay in a neonatal intensive care unit or NICU, where they can get special nutrition, extra care for their heart, help regulating their body temperature and help with their breathing.
NICUs are regularly successful in getting premature babies through the first part of their lives, but there’s always the danger of infection at a hospital. And if the baby needs to be put on a ventilator, it may injure their tiny lungs.
Before the FDA would approve experimenting with a human in an artificial womb, scientists would have to show that the device would be able to facilitate growth and development while reducing the rate of death and health problems, potentially compared with care with existing technology and techniques in a NICU.
The FDA’s Pediatric Advisory Committee will consider what kind of data scientists will have to show in such trials and what kind of regulations may need to be created, as well as what ethical considerations may need to be addressed. The committee will also discuss what kind of metrics may be needed to determine the success of animal trials.
A handful of scientists have been experimenting with animals and artificial wombs. In each study, the artificial womb is constructed a little bit differently.
In a 2017 experiment, a group at the Children’s Hospital of Philadelphia was able to keep a developing lamb alive for 28 days in a sterilized plastic bag filled with fluid. Tubes that delivered amniotic fluid, medicine and oxygen were connected to the lamb’s umbilical cord tissue. The team saw positive growth and development in the lambs’ lungs, brains and gastrointestinal tracts.
The group hopes to try a device they’ve been testing named the Extra-uterine Environment for Newborn Development, or EXTEND, in humans.
In a trial of what scientists at the University of Michigan call an artificial placenta, lambs survived 16 days. The team saw positive results in the development of lung function and brain development until they were able to transition to mechanical ventilation.
In an experiment in Japan and Australia, in an artificial womb scientists call EVE, the lamb incubated for a week and had good development in the lungs, but there was some brain injury due to a technical issue.
Scientists at the University of Toronto used fetal pigs in it experiment with an artificial placenta. Pigs and humans have a similar kind of umbilical cord, but there were problems with blood circulation and some heart issues in that experiment.
Experts say there may also need to be a conversation about what viability — a concept referring to the ability of a human to survive outside the womb — means.
If an artificial womb was ultimately approved for use with humans, doctors will have to have conversations with parents about how successful such an intervention could be. An ethical discussion is also on the FDA advisory committee’s agenda.
Additionally, the committee will discuss regulatory considerations and extra safeguards because trials would involve children, which by law requires extra steps to ensure safety. The advisers will examine potential clinical considerations to fairly assess whether the new technology would be an advance over currently available care.
Although the two-day meeting can guide the way the FDA will move forward with regulating artificial wombs, but agency makes decisions on its own terms and does not have to follow the experts’ recommendations.
The first day of hearings will be open to the public, but the second day will be closed because the nature of the research involves proprietary information, the FDA said.
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