Future of ‘Artificial Wombs’ for Human Preemies to Be Weighed by FDA Advisers

Future of ‘Artificial Wombs’ for Human Preemies to Be Weighed by FDA Advisers

TUESDAY, Sept. 19, 2023 — Advisers to the U.S. Food and Drug Administration will weigh the possibilities and parameters of experiments with artificial wombs for premature human babies. Scientists have already had some success with the concept in animals.

During a two-day meeting that ends Wednesday, the Pediatric Advisory Committee will cover regulations and ethics around creating an artificial womb that would help very premature humans to survive, with time to continue to develop their lungs, gastrointestinal system, and brain. The advisers will also consider what clinical trials for this would look like. The purpose of an artificial womb would be to help the fraction of babies born before 28 weeks of gestation, which is less than 1 percent of infants. It could not be used from conception to birth, CNN reported.

The two-day hearing will be open to the public on the first day but closed the second day while proprietary information is shared, CNN reported. The advisers will consider what data are needed to show a successful trial in both animals and humans. It will consider what ethical issues it needs to work through.