Artificial womb human trials may soon inch closer to reality
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The US Food and Drug Administration (FDA) will hold a meeting of independent advisors on September 19-20. The meeting’s agenda is to discuss the viability of clinical trials using artificial womb technology to improve the survival and health of extremely preterm newborns.
Reportedly, during this meeting, regulators and experts will delve into ethical concerns and evaluate various crucial aspects, including the potential steps and design of human trials for this technology.
Artificial womb for preterm babies
A fertilized egg normally takes nine months to mature into a roughly seven-pound baby.
However, complications may emerge along the way to welcoming a new life, potentially affecting the health and well-being of both the mother and the developing fetus.
Infection, hormonal changes, hypertension, and diabetes can render the womb an unfavorable environment for the growing fetus.
This can result in premature births, occurring well before the usual healthy pregnancy duration of around 40 weeks.
The current standard of care involves the use of incubators, which are used to keep premature babies warm and safe until their bodies reach a sufficient level of development to thrive outside the neonatal intensive care unit (NICU) in the hospital.
With the rapid advancement of medical research and technology, artificial wombs are seen as the next major breakthrough.
This is a developing medical technique that aims to provide a controlled environment outside the mother’s womb for the gestation and growth of extremely preterm newborns. Artificial womb technology will be meant specifically for babies born at fewer than 28 weeks gestation that may have an increased risk of death and morbidity.
The artificial womb tested in a lamb
Reportedly, the Children’s Hospital of Philadelphia (CHOP) has been seeking a nod from the FDA to commence the first human clinical trials of an artificial womb device called the Extra-uterine Environment for Newborn Development, or EXTEND.
CHOP researchers established the feasibility of an artificial womb called the "Biobag" to nurture a premature lamb back in 2017.
The Biobag was infused with lab-created amniotic fluid, mimicking the natural liquid environment surrounding a fetus in the womb.
Other necessities, such as a constant supply of oxygen, were introduced into the fetal bloodstream via a device linked to the umbilical cord.
The findings showed that lamb continued to grow within the Biobag for up to four weeks after being taken from the natural womb at the equivalent of 23-24 weeks in a human pregnancy.
“Our system could prevent the severe morbidity suffered by extremely premature infants by potentially offering a medical technology that does not currently exist,” said Alan W. Flake, MD, a fetal surgeon at CHOP, in a 2017 press release.
Overall, the FDA briefing document mentioned that viable clinical human trials for an AWT device must provide evidence to "support normal growth and organ maturation, while reducing high rates of prematurity-associated morbidities observed with current NICU standard of care, in infants born extremely premature."
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