FDA to discuss initial human testing of artificial womb for babies

The first artificial womb for growing human babies could be getting closer to reality.

Next week, the U.S. Food and Drug Administration will discuss how scientists should conduct initial human tests using bag-like wombs.

According to the FDA, the 2-day discussion with experts that starts on Sept. 20 will be about how these wombs could support "extremely premature babies" who struggle with current standard medical care.

Philadelphia's Vitara Biomedical is close to human trials for their artificial womb, based on lamb testing.

"The impact of this technology will be life-changing. It will be a new paradigm in pediatrics," Dr. Alan Flake, co-inventor and Vitara Medical Advisor, said on the company's website.

Vitara's artificial womb is a fluid-filled bag connected to tubes and machines and kept in a temperature-controlled environment. The tubes deliver amniotic fluid, while others provide oxygen and medications to the fetus through umbilical blood vessels, according to the Children’s Hospital of Philadelphia.

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The aim is to help babies born between 23 and 28 weeks of pregnancy, experts say.

While this concept has been studied over the past 60 years, in 2017 and 2019 two research groups demonstrated the basic concept of artificial womb technology through animal studies, with many experts agreeing that it's a positive advancement for science but poses an ethical concern when using the technology with humans, according to the National Institutes of Health.

"The ethical dilemma arises with, I think, inappropriate application of the technology to extend the limits of viability," Dr. Flake told the New York Times, adding that candidates for an artificial womb would be "infants that would currently not be resuscitated."

According to Vitara, around 15 million babies are born prematurely each year globally, with a worldwide preterm birth rate of about 11%. In the U.S., this leads to an economic burden of approximately $26 billion. Vitara hopes their technology will lower the costs that come with caring for those babies.