MORGAN ZEGERS: Human trials for artificial uterus designed for premature babies could begin this year

Several questions are raised regarding the efficacy of conducting experiments on humans who cannot consent to the procedures they would be subjected to

Several questions are raised regarding the efficacy of conducting experiments on humans who cannot consent to the procedures they would be subjected to

Scientists working at the Children’s Hospital of Philadelphia (CHOP) have successfully completed 300 animal trials using an artificial uterus or “womb” — meaning that human trials could be set to begin this year.

The artificial uterus, named the Extra-uterine Environment for Newborn Development or “EXTEND,” was first tested on gestating lambs, which were found to experience “normal brain development and stable nutrition,” according to the Daily Mail, “as if they were feeding off their mother.”

The FDA has reportedly met with the researchers to explore the next steps in bringing the artificial uterus to human trials, which could take place in 2024.

The gestation sac, which, according to Nature Journal’s description, “appears to be an oversized sandwich bag filled with hazy fluid,” is meant to aid only premature deliveries, not to carry the baby from conception to delivery.

Premature or preterm births occur anytime a baby is delivered before 37 weeks gestation, which in 2022, occurred to approximately 1 of every 10 infants born in the United States, according to Centers for Disease Control (CDC) data. “Babies born too early (especially before 32 weeks) have higher rates of death and disability,” the CDC explains. Specifically, babies born preterm have underdeveloped lungs, which make the transition from inhaling amniotic fluid to air more difficult, as well as underdeveloped brains and livers.

According to the Daily Mail, the team developing EXTEND conducted 300 successful tests on lambs, writing, “The typical gestation period of a lamb is 152 days. Researchers shared that by the end of the test animals’ stays in the artificial womb, they had a stable nutritional status, even though the lambs were not feeding on a sheep.” Researchers also conducted liver tests which “were positive, and brain growth was normal.”

“The animals demonstrated normal or increased movement, sleep/wake cycles, intermittent breathing and swallowing and generally appeared comfortable and nondistressed,” the CHOP team shared. Emily Partridge, a pediatric and fetal surgeon and researcher with CHOP, said that EXTEND is designed to be a “bridge” — to take struggling prenatal babies and “carry them through to a point when they can do okay.”

Though the animal tests have proved successful, the research team still faces numerous medical and ethical hurdles prior to being given FDA approval to begin human trials. Several questions are raised regarding the efficacy of conducting experiments on humans who cannot consent to the procedures they would be subjected to, and the duress the parents would be under at the time of consenting to take part in the trials.

Regarding the following steps, FreeThink explained that “No decisions have been made based on the meeting [between researchers and the FDA] — the panel can only advise the FDA, not actually give the green light for trials.”

This piece first appeared at TPUSA.


Image: Title: artificial womb
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