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A group of US researchers who first performed the “artificial womb” experiment in 2017 are now requesting Food and Drug Administration (FDA) approval for their testing on humans, a report says.
The technology, which simulates the womb and potentially lower fatalities and disabilities for babies born extremely prematurely, is expected to be taken into consideration by regulators, according to an article in Nature.
Preterm birth is the leading cause of death and disability in children under five, according to the World Health Organisation.
There will be roughly 13.4 million of these births worldwide in 2020.
A developing lamb was kept alive for 28 days in 2017 by researchers at Pennsylvania’s Children’s Hospital of Philadelphia (CHOP), where it was given amniotic fluid, medication, and oxygen through tubes attached to umbilical cord tissue.
The results of the experiment demonstrated that the lamb’s lungs, GI system, and brain were all developing healthily.
The Extra-uterine Environment for Newborn Development, or EXTEND, device that the CHOP team has been developing has now applied for permission for its first human clinical trials.
The team has made it clear that the technology is not meant to sustain development from conception to birth, nor is it capable of doing so. Instead, it could mimic some aspects of a natural womb, which would boost survival and improve outcomes for vulnerable babies.
In a 2017 video, Alan Flake, a foetal surgeon at CHOP who has been leading the effort, was quoted as saying, “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 prematurely onto a ventilator.”
Flake is one of several members of the CHOP team that has joined the Philadelphia-based startup Vitara Biomedical. Since then, it has raised $100 million to develop EXTEND.
The FDA’s gathering of independent experts is intended to address legal and moral issues as well as possible designs for human trials of the technology. This is going to be definitely an exciting step and it’s been a long time coming Kelly Werner, a bioethicist and neonatologist at Columbia University Medical Centre in New York City, was cited as saying. She also stated that clinicians who work with premature-born infants will be closely following this meeting.