Revolutionary Breakthrough: FDA Advisers Explore Groundbreaking Potential of Artificial Womb for Human Infants
FDA advisers to debate regulations and ethics of artificial womb for premature babies, aiming to boost survival rates and minimize long-term health issues
Independent advisers to the US Food and Drug Administration are scheduled to convene on Tuesday and Wednesday to deliberate on the regulations, ethics, and potential ramifications of developing an artificial womb. The aim of this innovative technology is to enhance the survival rates of extremely premature babies while minimizing long-term health issues. While human trials have yet to be conducted, the experts will explore the potential parameters and considerations for such experiments, taking into account previous successful implementations in animals.
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An artificial human womb could revolutionize healthcare by addressing a significant health issue. The disturbing reality is that preterm births, as highlighted by the World Health Organization, are the leading cause of death for children under the age of 5.
Premature babies face a multitude of lifelong health complications due to their underdeveloped lungs and brains. These complications encompass difficulties in breathing, gastrointestinal complications, visual and auditory impairments, developmental delays, and even cerebral palsy.
In light of this, the development of an artificial womb holds immense potential to mitigate such risks and enhance overall child health.
Prematurity is a growing concern in the United States, with the percentage of preterm births rising from 10.1% in 2020 to 10.5% in 2021, as reported by the US Centers for Disease Control and Prevention. This issue has a disproportionate impact on African Americans, who experience a 50% higher rate of premature birth compared to White and Hispanic individuals.
It's important to note that an artificial womb does not aim to replace a pregnant individual and cannot be utilized throughout the entire conception-to-birth process. Instead, its potential lies in assisting a small group of infants born before 28 weeks of pregnancy, which is categorized as extreme prematurity. These cases account for less than 1% of all births.
Infants born at earlier gestational ages face higher mortality rates. For instance, a mere 30% of babies born at 22 weeks survive, while just under 56% survive if born at 23 weeks, as noted in a 2022 study featured in the journal JAMA.
The potential of an artificial womb lies in supporting the baby's continued growth during critical stages of lung and brain development. Comparable to a natural womb, it would provide essential elements like oxygen, nutrients, and hormones.
Premature infants require the specialized care provided in a neonatal intensive care unit (NICU). In the NICU, they receive tailored nutrition, cardiovascular support, assistance in maintaining proper body temperature, and respiratory support.
Although NICUs are generally successful in guiding premature babies through their initial stages of development, the risk of infection at the hospital is ever-present. Additionally, the use of a ventilator can potentially harm their delicate lungs.
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Before giving approval for experimentation on a human in an artificial womb, the FDA requires scientists to demonstrate that the device can support growth and development, while also reducing mortality and health issues. This should be compared with the care provided by existing technology and techniques in a NICU.
The Pediatric Advisory Committee of the FDA will evaluate the requisite data to be presented in such trials, potential regulations that should be established, and the ethical considerations that must be addressed. Additionally, the committee will deliberate on the metrics necessary to ascertain the efficacy of animal trials.
A select group of scientists has been conducting experiments involving animals and artificial wombs. Each individual study involves a unique construction of the artificial womb.
In a 2017 study, researchers at the Children's Hospital of Philadelphia were successful in sustaining the life of a developing lamb for 28 days using a sterilized plastic bag filled with fluid. This was achieved by connecting tubes to the lamb's umbilical cord tissue to deliver amniotic fluid, medicine, and oxygen. Encouragingly, positive growth and development were observed in the lamb's lungs, brains, and gastrointestinal tracts. The team now aims to test their device, known as the Extra-uterine Environment for Newborn Development (EXTEND), on human subjects.
Scientists at the University of Michigan conducted a trial of an artificial placenta, leading to the survival of lambs for 16 days. Remarkably, the team observed promising improvements in lung function and brain development until a successful transition to mechanical ventilation.
Similarly, in a trial conducted in Japan and Australia, researchers utilized an artificial womb known as EVE. The lamb incubated within EVE for a week, displaying positive lung development. However, a technical complication led to some unfortunate brain injury.
Scientists at the University of Toronto conducted an experiment involving an artificial placenta, using fetal pigs. While pigs and humans have comparable umbilical cords, the experiment encountered complications related to blood circulation and certain cardiac issues.
Experts suggest the necessity to discuss the concept of viability, which pertains to a human's capacity to survive beyond the womb.
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Doctors will need to discuss with parents the potential success of using an artificial womb for humans. The FDA advisory committee also plans to engage in an ethical discussion on this matter.
Furthermore, the committee will address regulatory concerns and implement additional safety measures during the trials involving children, as mandated by law. The advisors will carefully assess the new technology's potential clinical implications to determine if it offers an improvement over current care options.
The FDA can use the two-day meeting to shape regulations for artificial wombs, but it is not obligated to follow the recommendations of experts. While the first day of hearings will be open to the public, the second day will be closed due to the involvement of proprietary information, according to the FDA.
