A Food and Drug Administration (FDA) advisory committee met last week to discuss human trials of artificial wombs, which could one day be used to keep extremely premature, or preterm, infants alive.
Artificial wombs have been tested with animals, but never in human clinical trials. The FDA has not approved the technology yet, but the advisory panel discussed the available science, as well as the clinical risks, benefits and ethical considerations of testing artificial wombs with humans.
“It’s a new treatment modality,” Matthew Kemp, an obstetrician at the National University of Singapore, tells Nature News’ Max Kozlov. “The bottom line is they’ve got to make a really strong case that it’s better and safer in the short and long term” compared to current treatments.
In 2020, an estimated 13.4 million babies worldwide were born prematurely—or before 37 weeks of pregnancy—making up more than 10 percent of all births. Preterm birth is the leading cause of death for children under five years of age, according to the World Health Organization.
Premature births have the most risk associated when they occur in the first 26 weeks of pregnancy. Approximately 70 percent of babies born at 24 weeks survive to discharge or one year, and even fewer survive earlier births—just 56 percent of babies born at 23 weeks and 30 percent born at 22 weeks survive, according to briefing materials from the FDA. Extremely premature babies who do survive are at risk of developing health problems or neurodevelopmental impairment.
Current treatments include placing the premature baby in an incubator, connecting them to a ventilator and feeding them nutrients and fluids through a tube.
Artificial wombs, however, are designed to more closely resemble the prenatal environment. The company Vitara Biomedical is working on an artificial womb that looks like a plastic bag, with tubes that deliver amniotic fluid, oxygen and medication, writes the Wall Street Journal’s Liz Essley Whyte. The technology has been tested on animals including lambs and pigs.
Notably, artificial wombs cannot grow a baby from conception to birth—researchers do not intend to have them replace a human mother. Instead, the technology is meant to support infants born before 28 weeks into pregnancy, according to CNN’s Jen Christensen.
In order for the treatment to enter clinical trials, artificial wombs would have to be shown to facilitate growth and development as well as reduce deaths and health problems in preterm babies, relative to standard treatments.
Last week, the FDA panel said that before testing with humans, scientists should figure out the most appropriate animal model to test in an artificial womb, CNN reports. They suggested human trials be inclusive and involve follow-up testing to examine any long-term consequences—including complications that might come from development in a device made of materials like plastic.
And parents, panelists said, would have to be informed about the risks of using an artificial womb, which might include infections, brain damage or heart failure, along with the risks of the caesarean section needed to remove the baby from the mother, writes the Wall Street Journal.
The FDA does not have to follow the panel’s recommendations, but the topics discussed will likely guide the agency as it considers artificial wombs.
The technology is “an amazing first step to potentially extending viability and improving morbidity and mortality outcomes for our preterm newborns,” neonatologist Shaliz Pourkaviani says to ABC News’ Evelyn Huang.
However, Kemp tells Nature News that “the data aren’t there from an ethical position” to justify starting human trials, unless “someone is sitting on a bunch of data that isn’t published.”
Stephanie Kukora, a neonatologist at Children’s Mercy Kansas City, says to the Wall Street Journal that choosing between participating in a trial and the current standard care “would be a really hard decision. The odds aren’t great with conventional therapy, but we at least sort of know what they are.”
“I don’t know what I would do,” she tells the publication.
Some researchers tell Nature News that funding research about the causes of preterm births might reduce the number of premature babies and lessen the need for artificial wombs in the future. Anna David, a maternal-fetal specialist at the University College London, tells the publication that scientists should explore why premature births occur and how they can be prevented.
“Artificial wombs will impact only a tiny fraction of the problem,” she says to Nature News.