Scientists want to try an artificial uterus on humans: it could help premature babies
U.S. Food and Drug Administration (FDA) officials this week discussed regulations, ethics and the feasibility of creating an artificial womb. It will increase the chances that very premature babies will survive - and without long-term health problems, reports CNN.
Although no such device has been tested in humans, similar devices have been used in several cases to successfully develop animals. On Sept. 19, the first day of their two-day meeting, advisers discussed what human trials might look like.
Solution to a big problem
An artificial womb for humans would be a scientific advance that could help solve a serious health problem. According to the World Health Organization, preterm birth is the number one killer of children under 5 years of age.
Because a baby's lungs and brain stop developing late in pregnancy, a baby born prematurely risks lifelong health problems, including breathing problems, gastrointestinal problems, vision and hearing problems, developmental delays and cerebral palsy.
Prematurity has become a growing problem in the United States. Premature births rose from 10,1% of all babies born in 2020 to 10,5% in 2021, according to the U.S. Centers for Disease Control and Prevention. This problem disproportionately affects African Americans, who give birth prematurely at a 50% higher rate than whites and Hispanics.
An artificial uterus is not intended to replace a pregnant woman. It cannot be used from conception to birth. Rather, it could be used to help the small number of babies born before 28 weeks of pregnancy, which is considered extreme prematurity. Less than 1% of children are born this early.
The earlier a baby is born, the higher the risk of death. For example, only about 2022% of babies born at 30 weeks survive, and just under 22% survive birth at 56 weeks, according to a 23 study published in JAMA.
An artificial womb could help a baby develop further in the vital final stages of lung and brain development. Like the human uterus, it will supply oxygen, nutrients and hormones.
Premature babies should remain in the NICU, where they can receive special nutrition, extra care for their heart, help regulating their body temperature, and help with breathing.
NICUs regularly treat premature babies successfully, but there is always a risk of infection in the hospital. And if a baby needs to be put on a ventilator, it can damage his tiny lungs.
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Before the FDA will approve human experiments in an artificial womb, scientists will have to show that the device can promote growth and development while reducing mortality and health problems, potentially compared to care with existing technologies and techniques in the intensive care unit.
The FDA's Pediatric Advisory Committee is considering what data scientists would be required to provide in such studies and what regulations might be required, as well as what ethical considerations might need to be taken into account. The committee also discussed what metrics might be needed to determine the success of animal testing.
Several scientists have experimented with animals and artificial wombs. In each study, the artificial uterus is designed slightly differently.
In a 2017 experiment, a team at Children's Hospital in Philadelphia was able to keep a developing lamb alive for 28 days in a sterilized plastic bag filled with liquid. Tubes that delivered amniotic fluid, medication and oxygen were connected to the lamb's umbilical cord tissue. The team observed positive growth and development of the lungs, brain and gastrointestinal tract.
“The technology is reliable and stable,” Dr. Alan Flake, director of the Center for Fetal Research at the Children's Hospital of Philadelphia, told the committee Sept. 19. “We are now raising over 300 lambs in the artificial womb and the overall process has been remarkably smooth.”
“We did not observe any acute, irreversible, survival-threatening events,” he added. “The primary safety feature is that if necessary, the subject can be immediately removed and placed in standard care.”
“We believe that our preclinical data support feasibility and safety and are sufficient to warrant consideration of a well-designed clinical trial of artificial womb technology,” Flake told the committee.
The group hopes to try out a device they are testing, called the Ectopic Environment for Newborn Development (EXTEND), in humans.
In a trial of what scientists at the University of Michigan call an artificial placenta, the lambs survived 16 days. The team saw positive results in the development of lung and brain function until they were able to switch to mechanical ventilation.
In a presentation to the committee Sept. 19, Dr. George Michaliska, Robert Bartlett Collegiate Professor of Pediatric Surgery at CS Mott Children's Hospital at the University of Michigan Health, said the group is working on a prospective study incorporating this work. They plan to use this artificial placenta in humans as a kind of “rescue therapy.”
“However, we recognize that there are many ethical and regulatory considerations that must be taken into account before clinical translation,” Michaliska said.
In another experiment conducted in Japan and Australia, in an artificial womb that scientists called EVE, a lamb was incubated for a week and had good lung development, but suffered a brain injury due to a technical problem.
Scientists from the University of Toronto used pig embryos in an experiment with an artificial placenta, simulating experiments with lamb. Pigs and humans have a similar type of umbilical cord, but in this experiment there were circulatory problems and some heart problems.
Despite the setbacks, Mike Seed, chief of cardiology at Toronto Children's Hospital, believes they are on the right track.
“We remain very enthusiastic about the potential of artificial womb technology and are about to begin a new series of experiments using the third iteration of our design,” he told the committee.
The FDA committee agreed that before such technology can be used in humans, scientists will have to determine the most suitable animal model for testing an artificial uterus.
Experts say there may also need to be a conversation about what viability means, a concept that refers to a person's ability to survive outside the womb.
On Sept. 19, the committee discussed at length the ethics of using the technology, including what conversations doctors might have to have with parents about how successful such an intervention might be if it were tested in humans.
The consultants also wanted to make sure that if the trial involved people, it would be inclusive. And they agreed that extensive follow-up would be necessary to determine what, if any, health effects on children would appear in the long term.
In addition, the committee discussed regulatory issues and additional safety measures since the trial will involve children, which legally requires additional safety measures. Consultants examined potential clinical considerations to fairly assess whether the new technology would be an improvement over currently available medical care.
While the two-day meeting could determine how the FDA moves forward in regulating the issue of artificial wombs, the agency makes decisions on its own terms and is not required to follow expert recommendations.
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The FDA said the first day of the meeting was open to the public, but the second day will be closed due to the nature of the study involving sensitive information.
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