While much of the existing artificial womb technology (AWT) research shows promise, the US Food & Drug Administration’s Paediatric Advisory Committee (PAC) says the logistical and ethical concerns previously raised by the agency are “complicated”.
AWT is meant to mimic the functions of a womb for extremely preterm infants, but while animal models of AWT appear promising, the technology hasn’t been tested in people yet.
Reviewing data from studies on animals – including lambs and piglets – some PAC members were uncomfortable with the idea of making the jump to human trials, reports MedPage Today.
Informed consent, ethical considerations
PAC members have emphasised the need for robust informed consent measures, highlighting the importance of culturally competent education about AWT.
Focus groups for racially and culturally diverse women with high-risk pregnancies could help inform this education, some have suggested.
“We need to make sure the parents are fully aware of the technology and understand what they’re being asked to participate in,” said PAC chairperson Dr Robert Dracker, of SUNY Upstate Medical Centre in New York.
Committee members have also questioned whether AWT would put mothers at risk any more than the current standard of care, or whether it could be weaponised to extend the foetal viability line.
Dr Mark Mercurio, director of the biomedical ethics programme at Yale School of Medicine in Connecticut, has suggested a meeting to discuss the ethics surrounding AWT, which has been supported by several committee members.
Some members recommended having informational brochures about AWT available in ob/gyn offices where mothers could familiarise themselves with the option, should they deliver extremely preterm.
Clarity on monitoring
The FDA has said that an AWT trial would probably start with one patient at a time, and PAC members said they want to know what metrics should be considered before enrolling more patients.
Dr Robert Nelson, senior director of paediatric drug development at Johnson & Johnson and the industry representative on the PAC panel, said that while long-term data on infant and maternal health are vital, waiting several years after the first AWT human trial to continue research would not be realistic.
The FDA would "need to come up with some short-term measures, because otherwise this technology would be in development for the next 15 years before there are any meaningful data”, he added.
Other PAC members have expressed concern over the long-term health effects that AWT could have on infants, with some noting that disability and quality of life might be as important as survival.
It would be useful to know what potential adverse events could affect infants in an artificial womb and how those events would be reported, they said.
Clarity of financial liability – including what entities would foot the bill for problems families may have down the line – was also necessary, they added.
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