Specialists in fetal and neonatal medicine at BCNatal have created an artificial placenta that simulates the conditions of the mother’s womb with the aim of saving future babies born before 26 weeks of gestation.
In a first trial with sheep, fetuses have survived twelve days in a container with amniotic fluid. So that the umbilical cords could develop properly, they were 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”, explained yesterday at a press conference Eduard Gratacós, project leader and director of BCNatal, a center attached to Clínic and Sant Joan de Ten. But before that, he warned, technology still needs to be improved to be able to help the most vulnerable premature babies.
Before the 26th week of gestation, the respiratory system, the digestive system and the brain of the fetuses are not yet ready to function autonomously outside the mother’s body. For this reason, the most extreme premature babies have a high mortality rate and many of the survivors are at high risk of lifelong sequelae.
The problem affects 25,000 newborns a year in Europe, which led Gratacós to prepare in 2020 the project to create an artificial placenta.
About 35 researchers from different disciplines participated in the adventure. “To get a fetus out of its mother and continue to live as a fetus, you have to deceive nature”, explained Gratacós. “It is unexplored territory, it has never been done in history”.
But he declared himself convinced that “this disruptive technology will exist in the future” and that “it will change the lives of many people”, just as transplants are common today, despite the fact that in the beginning they had to solve great scientific and technical challenges .
The results of the first thirty months of the project, in which around 50 sheep fetuses have been transferred to artificial placentas, were announced yesterday 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 most relevant result is that the time that the fetuses transferred to an artificial placenta have remained alive has progressively increased since the start of the project. It was less than three hours in March 2021, exceeded 24 hours a year later and reached twelve days in March of this year.
This progression predicts that survival time in the artificial placenta will continue to increase in the coming months and years as the technique continues to improve. The BCNatal team hopes to reach four weeks in the future, which would substantially improve the prospects of extreme premature babies.
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 – have ongoing artificial placenta projects, Gratacós reported. None of them have yet reached the point where they can apply the technology to people.
The one at the Children’s Hospital of Philadephia is the most advanced, with a survival of 28 days in artificial placenta, while the one at BCNatal is on its way to becoming the first in Europe to bring this advance into clinical practice .
The project has been financed from the beginning by the La Caixa Foundation, which is why it is called CaixaResearch Artificial Placenta. The foundation has provided 3.35 million euros for the first phase and will provide another 4.3 million for the second, which starts now and will last until 2027.
In this second phase, trials with sheep will continue and will be extended to pigs. The goals are to prolong the survival time of fetuses in the artificial placenta and to prepare the protocols so that the fetuses, once they are more developed, can make the transition to life outside the placenta.
Before carrying out the first clinical study with human fetuses, the BCNatal team must study in animals the consequences of having passed part of the pregnancy to 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, it is hoped to be able to carry out a first human study in a compassionate use therapy context in the second half of this decade.