This week, independent FDA advisers discussed artificial wombs’ regulations, ethics, and potential to improve highly premature infants’ survival odds and reduce long-term health risks.
While human trials of such devices have yet to be conducted, animal experiments have yielded promising results.
During the first day of their two-day meeting, the FDA advisers delved into the prospects of human trials and what they might entail.
The concept of an artificial womb for humans carries the promise of a groundbreaking scientific advancement that could address a pressing global health issue.
Preterm births, responsible for more child deaths under the age of 5 than any other cause according to the World Health Organization, result in a range of lifelong health challenges, including respiratory difficulties, gastrointestinal problems, sensory impairments, developmental delays, and even cerebral palsy, as an infant’s lungs and brain typically complete their development late in pregnancy.
The prevalence of prematurity has surged in the United States, with preterm births increasing from 10.1% of all births in 2020 to 10.5% in 2021, as the US Centers for Disease Control and Prevention reported.
Alarmingly, this issue disproportionately affects African Americans, with a 50% higher rate of premature births compared to White and Hispanic populations.
It is crucial to clarify that an artificial womb does not seek to replace a traditional pregnancy. Instead, it aims to aid a select group of infants born before the 28th week of pregnancy, defined as extreme prematurity, which accounts for less than 1% of all births.
The earlier an infant is born, the greater the risk of mortality. For instance, only approximately 30% of infants born at 22 weeks survive, and just under 56% survive birth at 23 weeks, according to a 2022 study published in the journal JAMA.
FDA Criteria for Human Trials of Artificial Wombs: Evidence, Ethics, and Metrics
Before the FDA would consider permitting human experimentation with an artificial womb, scientists would need to provide compelling evidence that the device can support growth and development while lowering mortality rates and health issues compared to existing Neonatal Intensive Care Unit (NICU) care.
The FDA’s Pediatric Advisory Committee is currently deliberating the data requirements for such trials, potential regulatory frameworks, and ethical considerations.
The committee is also pondering the metrics necessary to gauge the success of animal trials.
A select group of scientists has already conducted experiments involving animals and artificial wombs.
In each study, the artificial womb’s design varies. In a notable 2017 experiment, researchers at the Children’s Hospital of Philadelphia successfully maintained the life of a developing lamb for 28 days in a sterile plastic bag filled with fluid.
Tubes delivering amniotic fluid, medication, and oxygen were attached to the lamb’s umbilical cord tissue.
The results demonstrated positive growth and development in the lambs’ lungs, brains, and gastrointestinal tracts.
Dr. Alan Flake, director of the Center for Fetal Research at the Children’s Hospital of Philadelphia, attested to the stability and robustness of the technology, emphasizing that they had conducted over 300 experiments with lambs in artificial wombs.
The group’s next step involves attempting a device they’ve been testing, named the Extra-uterine Environment for Newborn Development (EXTEND), in humans.
The FDA advisory committee concurred that scientists must identify the most suitable animal model to test the artificial womb effectively.
Moreover, discussions surrounding the concept of viability—referring to an infant’s capacity to survive outside the womb—have arisen as a pivotal consideration.
Ethical considerations are at the forefront of these discussions. This includes conversations between doctors and parents regarding the potential success of such interventions if tested on humans.
The advisers also emphasized inclusivity in clinical trials and recognized the need for extensive follow-up to assess any long-term health effects on the children involved.
Due to the involvement of children in these trials, additional regulatory considerations and enhanced safety measures are being contemplated.
The advisers are exploring clinical parameters to ensure a fair evaluation of the new technology’s advancement over existing care.
While the two-day meeting serves as a guiding discussion, the FDA ultimately makes regulatory decisions independently and is not bound by the advisory committee’s recommendations.
The first day of the meeting was open to the public, but the second day was closed due to the sensitive nature of the research involving proprietary information, as stated by the FDA.
The proceedings represent a significant step forward in the ongoing exploration of artificial wombs, offering a glimpse into the potential future of neonatal care.