Specialists in fetal and neonatal medicine from BCNatal have created an artificial placenta that simulates the conditions of the mother’s womb with the aim of saving babies born before 26 weeks of gestation in the future.
In a first test with sheep, the fetuses have survived twelve days in a translucent container with amniotic fluid. In order for them to develop correctly, their umbilical cord has been connected to an oxygenation and nutrition system specially designed for this project.
The artificial placenta could begin to be used with human fetuses “within three to five years,” Eduard Gratacós, project leader and director of BCNatal, an international reference center for fetal and neonatal medicine affiliated with the Clínic and Sant Joan de Déu hospitals. But first, he has warned, technology still needs to be improved in order to help the most vulnerable premature babies.
Before week 26 of gestation, the respiratory, digestive, and brain systems of fetuses are not yet ready to function autonomously outside the mother’s body, reported Gratacós. For this reason, the most extreme premature infants have a high mortality rate and many survivors are at high risk of suffering lifelong sequelae.
The problem affects 25,000 newborns a year in Europe, which led Gratacós to launch the project to create an artificial placenta in 2020. Only four other research groups in the world -two in the US, one in Canada and a fourth formed by a consortium between Australia and Japan- currently have artificial placenta projects underway, reports Gratacós. None of them have yet reached the point where they can apply the technology to people.
Some 35 researchers from different medical specialties, biology, nursing and engineering have participated in the BCNatal project. “In order to get a fetus out of its mother and to continue living as a fetus, you have to deceive nature,” explains Gratacós. “It is unexplored territory, it has never been done in history.”
But he has declared himself convinced that “this disruptive technology will exist in the future” and that “it will radically change the situation of thousands of cases (…) that represent family tragedies.”
The results of the first thirty months of the project, in which some 50 sheep fetuses have been transferred to artificial placentas, were announced today at a press conference and will be presented to the scientific community at the World Congress of Fetal Medicine to be held next week in Valencia.
The project has been financed since its inception by the Fundación la Caixa, which has contributed 3.35 million euros for the first phase and another 4.3 million for the second.
In this second phase, which begins now and will last until 2027, tests with sheep will continue and will be extended to pigs. The objectives are to prolong the survival time of the fetuses in the artificial placenta and to prepare the protocols so that the fetuses, once they are more developed, can make the transition to living outside the placenta.
Before carrying out the first clinical study with human fetuses, the BCNatal team must study in animals the consequences of having spent part of the pregnancy in an artificial placenta. In particular, they want to study the possible effects on neurological, cardiac, pulmonary and metabolic development.
If the results of the animal studies are positive, a first human study in a compassionate use therapy setting is expected to be possible in the second half of this decade.
“For the families of extremely premature infants, a moment that should be of maximum happiness turns into a journey full of uncertainty and anguish”, declares Antoni Vila Bertrán, general director of the foundation, who hopes “to achieve a solution that contributes to saving lives and to reduce the great consequences that some of these newborns present”.
