Max Kozlov Extra-uterine Environment for Newborn Development, or EXTEND Bold claims Ethics Those developing artificial wombs in the United States will also have to contend with a politically...
Max Kozlov
The lamb was one of eight in a 2017 artificial-womb experiment carried out by researchers at the Children’s Hospital of Philadelphia (CHOP) in Pennsylvania. When the team published its research1 in April of that year, it released a video of the experiments that spread widely and captured imaginations — for some, evoking science-fiction fantasies of humans being conceived and grown entirely in a laboratory.
Extra-uterine Environment for Newborn Development, or EXTEND
The researchers at CHOP are seeking approval for the first human clinical trials of the device they’ve been testing, named the Extra-uterine Environment for Newborn Development, or EXTEND. The team has emphasized that the technology is not intended — or able — to support development from conception to birth. Instead, the scientists hope that simulating some elements of a natural womb will increase survival and improve outcomes for extremely premature babies. In humans, that’s anything earlier than 28 weeks of gestation — less than 70% of the way to full term, which is typically between 37 and 40 weeks.
Preterm birth is the largest cause of death and disability in children under five. In 2020, there were about 13.4 million such births worldwide, and complications related to preterm birth caused about 900,000 deaths in 2019.
Bold claims
The CHOP group has made bold predictions about the technology’s potential. In another 2017 video describing the project, Alan Flake, a fetal surgeon at CHOP who has been leading the effort, said: “If it’s as successful as we think it can be, ultimately, the majority of pregnancies that are predicted at-risk for extreme prematurity would be delivered early onto our system rather than being delivered premature onto a ventilator.” In 2019, several members of the CHOP team joined a start-up company, Vitara Biomedical in Philadelphia, which has since raised US$100 million to develop EXTEND. (Flake declined to comment for this article, citing “conflicts of interest” and “restrictions on proprietary information.” His co-authors on the 2017 paper did not respond to Nature’s request for comment.)
The artificial womb “would bridge a baby born extremely premature through those days and weeks when they’re most at risk for lung and brain damage,” Werner says. The CHOP group has signalled that it would wean babies off its system after a few weeks, when their organs are more fully developed and their likelihood of healthy survival is higher.
Researchers who spoke to Nature say that the CHOP group’s system is probably closest to human trials. But groups in Spain, Japan, Australia, Singapore and the Netherlands are also developing artificial-womb technology.
Ethics
Safety questions won’t be the only ethical concerns. The development of artificial wombs represents a “big transformational leap” that “solves lots of issues,” says David. But, she adds, “it also opens up a whole new slew of issues.” After the 2017 study generated extensive media coverage, fears spread that artificial wombs could one day replace pregnancy.
But researchers discount these concerns. This idea “is so far in the distant future that it’s not worth discussing its implications in relation to the current technology,” Werner says.
Those developing artificial wombs in the United States will also have to contend with a politically charged environment for reproductive rights. Flake and Mychaliska have been careful not to give any indication that an artificial womb could change the definition of fetal viability — which has enormous implications after the US Supreme Court struck down the 1973 landmark abortion decision Roe v. Wade in June last year. Previously, the 1973 ruling had protected abortion until the fetus is viable outside the womb.
Concerns*
Some researchers also worry that artificial wombs would represent an expensive technological solution to a deeper problem. Michael Harrison, a fetal surgeon at the University of California, San Francisco, sometimes called the ‘father of fetal surgery,’ says the data he has seen so far have been promising. But he questions whether it’s worth “throwing all that money and tech” on babies that have a poor likelihood of survival instead of finding ways to improve pregnancy support or standard techniques for preterm critical care, which could reduce the need for artificial-womb technology in the long run.
David agrees, adding that there is insufficient research and funding to understand why women go into labour early and how to prevent it. “We need to get real with this,” she says. “Artificial wombs will impact only a tiny fraction of the problem.”
Bartlett says that systemic measures are important, but he argues that better treatment is urgently needed for extremely preterm babies. “A silver bullet that prevents prematurity doesn’t exist and is unlikely to exist in our lifetimes,” he says. “These technologies are what we need when the systemic measures fail.”
The US Food and Drug Administration (FDA) will convene a meeting of independent advisers on 19–20 September to discuss regulatory and ethical considerations and what human trials for the technology might look like. The committee’s discussion will be scrutinized by the handful of other groups around the world that are developing similar devices, and by bioethicists exploring the implications for health equity, reproductive rights and more.
Max Kozlov
Extra-uterine Environment for Newborn Development, or EXTEND
Bold claims
Ethics
Those developing artificial wombs in the United States will also have to contend with a politically charged environment for reproductive rights. Flake and Mychaliska have been careful not to give any indication that an artificial womb could change the definition of fetal viability — which has enormous implications after the US Supreme Court struck down the 1973 landmark abortion decision Roe v. Wade in June last year. Previously, the 1973 ruling had protected abortion until the fetus is viable outside the womb.
Concerns*