According to a recent report, a team of US researchers, known for their groundbreaking 2017 experiment involving artificial wombs, is now in the process of seeking approval from the Food and Drug Administration (FDA) to conduct human trials. The proposed trials would involve a system designed to replicate the conditions of a natural womb and have the potential to significantly reduce mortality and disabilities in extremely premature infants, as highlighted in Nature.
Preterm birth, the leading cause of death and disability in children under five, affects a staggering 13.4 million infants globally as of 2020.
In their 2017 experiment at the Children‘s Hospital of Philadelphia (CHOP) in Pennsylvania, scientists successfully sustained a developing lamb for 28 days in a sterilized container filled with fluid. The lamb received essential nourishment, amniotic fluid, medication, and oxygen through specialized tubes connected to umbilical cord tissue. The experiment demonstrated positive growth in the lamb’s lung, gastrointestinal tract, and brain development.
CHOP research team seeks approval for inaugural human clinical trials
The CHOP research team, now working under the banner of a start-up called Vitara Biomedical in Philadelphia, is seeking approval for the inaugural human clinical trials of their innovative device, known as the “Extra-uterine Environment for Newborn Development” (EXTEND). It’s important to note that this technology is not intended to support the entire developmental journey from conception to birth but rather aims to simulate certain aspects of a natural womb, ultimately enhancing survival rates and improving outcomes for extremely premature infants.
Alan Flake, a fetal surgeon at CHOP leading the initiative, expressed optimism in a 2017 video, stating, “If it’s as successful as we think it can be, ultimately, the majority of pregnancies predicted to be at-risk for extreme prematurity could be delivered early onto our system rather than being prematurely placed on a ventilator.”
The FDA is currently convening a meeting of independent advisers to deliberate regulatory and ethical considerations and discuss the potential framework for human trials involving this groundbreaking technology.
“This is undoubtedly an exciting step, and it’s been a long time in the making,” remarked Kelly Werner, a bioethicist and neonatologist at Columbia University Medical Center in New York City. She added, “Clinicians who work with premature babies will be closely following this meeting.”