Now, the team at CHOP have sought 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. Rather, it may simulate some elements of a natural womb and will increase survival, improve outcomes for extremely premature babies, the report 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 prematurely onto a ventilator,” Alan Flake, a fetal surgeon at CHOP who has been leading the effort, was quoted as saying in a 2017 video.
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Meanwhile, the FDA’s meeting of independent advisers aims to discuss regulatory and ethical considerations and what human trials for the technology might look like. “This is definitely an exciting step and it’s been a long time coming,” says Kelly Werner, a bioethicist and neonatologist at Columbia University Medical Center in New York City, was quoted as saying.” Clinicians who work with premature babies will be closely following this meeting,” she said.
Reference :
- Human trials of artificial wombs could start soon. Here’s what you need to know – (https://www.nature.com/articles/d41586-023-02901-1)
Source: IANS
