Federal regulators are discussing artificial wombs, an important step for doctor-researchers who want to conduct the first clinical trials for humans.
FDA advisers are meeting this week on artificial wombs Artificial Placenta Technology. The device won’t replace the human womb, but it could serve as a bridge to very premature babies, or what scientists are calling “newborns,” after they are born and as they grow.
Videos shared by researchers at the University of Michigan and Children’s Hospital of Philadelphia show what the technology looks like. An artificial womb may consist of a bag filled with synthetic amniotic fluid and tubes connected to the umbilical cord. They remove harmful carbon dioxide from the blood and bring in oxygen and nutrients.
Over the past six years, researchers say, these artificial wombs have helped with brain, lung and gut development in premature lambs and fetal pigs.
“We have been able to rapidly convert pig embryos, which are human in size, from placental support to circuit support with physiological blood flow,” said Dr. Alan Fleck, director of the Embryo Research Center at the Children’s Hospital of Philadelphia.
FDA advisors will discuss possible guidelines for first-to-human studies in preterm animals. Questions include how would it work to transport a patient to an artificial womb? What will qualify a patient for an artificial womb? What is an ethical way to design a first study?
Premature births are those at 37 weeks and younger. Many cases at 32 weeks or less are considered extremely preterm. CDC data shows 1 in 10 babies in America is born prematurely. Sixty-five percent of all infant deaths are premature babies.
It will still be many months, if not years, before any clinical trials in humans. Individual research hospitals will also have their own ethics and science reviews before any human trials are conducted.