2023-06-19 13:48:21
Survival of extremely premature infants, those born at less than 26 weeks of gestation, is very low. Among those who manage to survive, in addition, the appearance of serious sequelae is very frequent.
With these children and their families in mind, the BCNatal clinical and research center, attached to the Sant Joan de Du and Clnic de Barcelona hospitals, launched a project three years ago to create an artificial placenta capable of emulating the conditions that are produced in the womb. The objective of this device is to be able to prolong in these babies the adequate fetal development, minimizing the risk of mortality and sequelae.
Three years later, the researchers have shown that the project is viable. According to the data presented at a press conference, the team has managed to develop a functional artificial placenta prototype and has achieved a 12-day survival in animal models, guaranteeing a good fetal state.
In experiments with sheep fetuses, the researchers have managed to achieve 12-day survival on three occasions, although they have also achieved several successful cases with 10 and 9-day survival, quite a “milestone”, as noted by Eduard Gratacsdirector of BCNatal and leader of the project, who stressed that “this is a very unique project that is determined to change the lives of thousands of people around the world.”
According to the forecasts of the team, “if everything goes well, in two or three years“Clinical trials could be started in the context of compassionate use therapy for humans and that in less than five years it would be available for clinical practice.
But first, he insisted, it is necessary to refine all the processes and ensure that “something that works almost always works always”.
In any case, the researchers stressed that the project is viable and that they have no doubt that “the artificial placenta is going to be a reality.”.
What is the artificial placenta
So far, the researchers have managed to develop a prototype that allows emulating the protected environment of the maternal womb through a translucent container made from biocompatible material that is connected to a circulation system that mimics amniotic fluid and allows the fetus to be maintained. “insulated from outside stimuli” that could hinder its development while making it possible to carry out external monitoring, as indicated by Elisenda Eixarchsenior scientific coordinator of the project.
Get one appropriate transition between the mother’s placenta and the artificial placenta has been challenging, the researchers explained. This change must be done very quickly and delicately, since the very small vessels of the umbilical cord are programmed to close very quickly. “The goal is to fool nature so that it doesn’t look like the baby was born,” Gratacs said. This transition between placentas must be done before the baby is born, when it is still taking oxygen and nourished through her mother’s placenta, so that later she can continue to develop in a liquid medium, they explained. “In the last 12 months, a successful transition has been achieved in 100% of cases,” said Eixarch.
La Caixa artificial placenta
The researchers, in addition, have also been able to create a system of extracorporeal circulation that allows to imitate the supply of oxygen and substances that is usually produced through the placenta and the umbilical cord. This system is composed of an oxygenating membrane and a system of parts designed to ‘copy’ the natural work of circulation.
In this sense, protocols have also been developed so that the administration of nutrition, hormones and other substances necessary for the fetus It is done at the right time based on development requirements.
Finally, the group, made up of more than 35 people and 30 collaborators, has also created a system of continuous monitoring with remote access in real time that is not invasive, they told the press.
of Financiac
“This is one of the most unique and disruptive research projects that can be done in fetal medicine today,” Gratacs said.
The project has received 4.3 million euros from the la Caixa Foundation for the second phase of the research. The entity already contributed 3.35 million for the first phase whose results have now been presented.
“It is totally unexplored terrain. We are facing many difficulties and it is important to move forward little by little,” remarked Gratacs, who announced that one of the goals of the second phase that is now beginning is to extend the survival time from the 12 days reached to the “three or four weeks”.
“Those weeks is what will allow us to achieve a radical change” in the approach to very premature infants, he said. “If we achieve this goal we could change the theoretical point of birth,” he added.
Before six months of pregnancy, babies’ lungs, digestive system, circulation or brain are not ready to adapt to the outside world. To survive, these children need to undergo different types of support and interventions, which can leave sequelae. For this reason, an artificial placenta that simulates the conditions of the mother’s womb can mean a substantial change for these children and their families.
As he explained, each year more than 25,000 children are born in Europe with six months of gestation or less. The survival of these little ones ranges between 25 and 75% and between 75% and a very high percentage of the survivors have sequelae.
The objective of the team is to optimize all the processes, achieving, in collaboration with the industry, improving all the devices and technologies necessary for the functioning of the artificial placenta.
“Many of the answers to the big biological questions we already have,” Gratacs said. The objective now is to industrialize all the gears and materials of the device, to guarantee safety and that everything works perfectly.
In the future, the artificial placenta could also be useful for fetal surgical approaches that, due to their complexity, cannot be performed intrauterinely today.
In addition, another of the researchers’ goals is to define what the ‘second’ birth of this fetus should be like, that is, the transition from the artificial placenta to extrauterine life. In addition to the studies in sheep fetus models, experiments will also be carried out in porcine moles, in which the long-term effects on brain, heart, lung and metabolic development will be studied.
The assessment of biotic issues is also a fundamental point for the team, so they will be addressed before applying for permits to start clinical trials.
For Manel del Castillogeneral director of the Sant Joan de Du Hospital in Barcelona, ”there are very few projects of these characteristics”, with the “purpose of changing the reality of ultra-premature children and their families”.
In the same line he pronounced Josep M. Campistolgeneral director of the Hospital Clnic de Barcelona, who appreciated the singularity “of a disruptive project that can change the natural history of many newborns with great difficulties”.
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