Although more than 90% of pregnancies are carried to term normally, foetal life remains one of the highest risk phases for humans and the artificial placenta technique represents a major advance

The "la Caixa" Foundation is promoting the first European project to create an artificial placenta

From left to right: Eduard Gratacós, director of BCNatal and leader of the project; Luisa Martínez, mother of a premature baby, and Antonio Vila, director general of the "la Caixa" Foundation, at the presentation of the disruptive artificial placenta project, unique in Europe

Antonio Vila, general director of the "la Caixa" Foundation; Josep Maria Campistol, general director of the Hospital Clínic in Barcelona; Manel del Castillo, managing director of the Hospital Sant Joan de Déu; Eduard Gratacós, director of BCNatal and leader of the project, and Àngel Font, corporate director of Research and Health at the "la Caixa" Foundation, presented the disruptive artificial placenta project, which is unique in Europe. The aim is to increase the survival of extreme premature babies and minimize the serious neurological sequelae suffered by a large proportion of newborns born prematurely, some 25,000 in Europe each year, and, in turn, to improve their quality of life and that of their families.  

Although more than 90% of pregnancies are carried to term normally, foetal life remains one of the phases of greatest risk to humans. One of the main unresolved problems is extreme prematurity (six months or less), which affects 25,000 families every year in Europe alone. Despite medical advances, recent major studies in Sweden and the United States indicate that no clear improvements have been made in the last 20 years. The survival of these babies, even in excellent health units, is between 25% and 75% and between 75-95% of the survivors present sequelae,

The reason for this is that, before the sixth month of pregnancy, the lungs, intestines and brain of the foetus are underdeveloped. An extremely premature newborn is in fact a fetus that must survive in a very unnatural environment. Weighing less than 1000 grams, changing temperatures, mechanical breathing and tube feeding, its nervous system, lungs, heart, intestines and kidneys are under great stress, which can have serious consequences in childhood and adulthood.

A disruptive solution to save the lives of premature babies

The idea of the artificial placenta is not new: it has been in existence for more than sixty years. But it is only in the last ten years that existing advances have led us to think about its real clinical application today. The artificial placenta project represents a great medical and technological challenge, as it will be necessary to successfully transport a fetus of between 500 and 1,000 grams from the maternal uterus to an artificial bag where, surrounded by a fluid as similar as possible to the amniotic one, its cord must continue to receive oxygen and food.

Dr. Gratacós has considered that “this is one of the most disruptive and unique research projects that can be carried out today in fetal medicine” in the world. “Only having an experimental platform like the one that is going to be built will allow parallel investigations of great importance to understand normal and abnormal fetal development,” he indicated. And he assures: "This will increase the capacity to attract investment for R+D+I in Barcelona, Catalonia and Spain".

A pioneering project, unique in Europe, which will be developed in two phases

The "la Caixa" Foundation will allocate nearly seven million euros to this pioneering project, which will be carried out in two phases over five years. The first phase will focus on the development and experimental validation of the placenta through the use of an animal model, specifically sheep, to later transfer it to clinical practice if the indicators of success are met. In the second phase, the already long-term effects on brain, heart, lung and metabolic development will be evaluated and improvements will be made mainly in the environment and nutrition to achieve the best system. Once these evaluations have been carried out, steps will be taken to transfer the system to a clinical application, including the assessment of all ethical aspects and incorporating the opinion and experience of families who have had a premature baby. 

A highly complex project: How will the artificial placenta work technically? 

In the artificial placenta, the neonate will be located in a liquid physical environment as close to the maternal uterus, inside a soft container made with biocompatible materials and protected from lights and sounds, although it is expected to be able to reproduce sounds similar to those of the maternal uterus. It will be connected through its umbilical cord to a developed and adapted oxygenator, which will provide it with oxygen, and will also receive nutrients, hormones and other substances that the fetus receives from the mother or that the placenta produces directly. The baby will be monitored by ultrasound for blood flow, blood pressure and heart rate, and the placenta will have two or three entrances to access the fetus through small robotic arms.

The "la Caixa" Foundation, a decade promoting BCNatal projects

The "la Caixa" Foundation has already collaborated in ten lines of research, to which it has allocated 6.5 million euros.  

The BCNatal's interdisciplinary research group, led by Dr. Gratacós, has been working on this project for two years now, in which they have already developed the main components of the placenta. To carry out the initiative, dozens of professionals from the Sant Joan de Déu and Hospital Clínic hospitals in Barcelona will be collaborating with the group, which also includes several technology centres in Barcelona, including, among the most important, the Chemical Institute of Sarrià (biomaterials), the Polytechnic University of Catalonia (robotics and artificial intelligence) and the Bioengineering Institute of Catalonia (microsensors). In addition, the project will have several supervisory committees made up of non-medical experts (in reproductive rights and bioethics, among others), and mothers and fathers of premature children. 

BCNatal is a joint centre within the Sant Joan de Déu Healthcare Group-Hospital Clínic. It is one of Europe's largest clinical areas for mother and baby and a pioneer in clinical and research work in foetal surgery. The centre receives doctors from the five continents for specialised training and is among the leading international scientific centres in its field.  

Evaluation process carried out by a committee of international experts

The project has undergone an international evaluation process governed by the most demanding standards for this type of initiative. The evaluators, of international prestige, belong to five countries: Australia, Spain, Israel, Portugal and the United Kingdom. All of them agreed on the excellence of the scientific strategy designed, the magnitude of the problem, and the need for alternative solutions such as the artificial placenta. They also stressed that BCNatal was one of the few centres in the world, and surely the only one in Europe, with the capacity to carry out a project of this magnitude.

Other similar projects around the world

There are currently only three groups in the world (Philadelphia and Michigan, United States, and Australia and Japan) that have developed experimental models in this regard, with significant advances in recent years.  

The reason is that their implementation is difficult in practice. On the one hand, it requires a large critical mass, which is only possible in large hospitals working in powerful biotechnology environments.  Moreover, they are projects that may require the participation of more than 100 people and numerous experts in a wide variety of fields. On the other hand, it is a very high-cost project, so it is very difficult to obtain the necessary funding for its implementation.