The Clínica Universidad de Navarra leads CARDIOPATCH, an international project with a double goal: to offer a solution final to patients with myocardial infarction through a "smart patch" capable of regenerating their cardiac lesion, and to boost the research and development+i of the biomedical and biotechnology sector in Southwest Europe.

Eight other public and private institutions from Spain, France and Portugal are cooperating in this project and it is co-financed with 1,064,250 euros by the European Union's Interreg Sudoe Program (transnational cooperation program in southwest Europe), through the European Regional Fund development (ERDF).

The importance of project lies in the fact that cardiovascular diseases are the leading cause of death in the world. According to the European Heart Network, these pathologies are responsible for the death of 45% of Europeans and represent a healthcare cost of 210 billion euros for the European Union.

A "smart patch" 2.0

The Clínica Universidad de Navarra and the Cima bring their expertise to the research in cell therapy and regenerative medicine. These two centers and Viscofan -business Spanish world leader in the manufacture and marketing of casings for meat products - developed a patch of collagen fibers impregnated with mesenchymal stem cells from fat, which is in the first phase of a clinical essay in patients with chronic ischemic cardiomyopathy.

The project CARDIOPATCH aims to optimize the therapeutic benefit of this patch by means of modification techniques Genetics and cell reprogramming. "For the design of this new 'patch 2.0' we will genetically modify mesenchymal stem cells from adipose tissue with micro-RNAs and viral vectors that induce the expression of pro-angiogenic and cardioprotective proteins. This will stimulate the training of new blood vessels in the damaged area of the heart and favor their repair. At the same time, we want to enhance the regenerative capacity of the collagen membrane by introducing cardiomyocytes, which are the cells that form the cardiac muscle. We will obtain these specialized cells through cellular reprogramming techniques derived from induced pluripotent stem cells, artificially created stem cells," explains Dr. Felipe Prósper, director of the area of Cell Therapy at Clínica Universidad de Navarra, manager , project.

On the other hand, notes Dr. Beatriz Pelacho, a researcher in regenerative medicine at Cima, "the project also seeks to functionalize the collagen membrane so that, in addition to supporting the 'boosted' cells, it releases therapeutic proteins". "To validate these strategies we will investigate their efficacy in animal models of infarction in rats and pigs, which is the best experimental model of cardiac damage," concludes the researcher.

Minimally invasive clinical application

In addition to the therapeutic validation of this new patch, together with partnership of biotechnology companies, the project plans to implement two other medical products: a rollable 3D device to facilitate minimally invasive implantation of the patch in the patient and a 3D system to generalize its production and facilitate its transport.

"The current surgical technique to implant the patch in a patient is by thoracotomy. Our goal is to develop a rollable 3D device that allows its implantation through a mini-thoracotomy. Thus, by means of the new design of the patch in a rolled format, we will be able to introduce it through a small incision and direct it to the damaged area of the heart. Once there, we can deploy it and attach it to the cardiac lesion to activate its regeneration," says Dr. Prosper.

According to Dr. Pelacho, "the translational vision of CARDIOPATCH encompasses innovation in how to get the 2.0 patch to the patient. For this reason, the project includes a logistic proposal of design in 3D prototypes for the preparation and transport of these improved patches for future widespread application in the clinic".

network public-private ' of Excellence' in research and development+i in advanced therapies

Cardiovascular diseases represent a challenge for the regions of southwestern Europe. According to the latest official data in each country, more than 120,000 people die each year in Spain (high school National Statistics Office), 140,000 in France(Ministry of Solidarity and Health) and nearly 35,000 in Portugal(Portuguese Health Service). These data are accompanied by high morbidity fees and an important health expense in these regions.

Thus, CARDIOPATCH is configured to create a 'network of Excellence' to promote the research and development+i of the biomedical and biotechnology sector in Southwest Europe. To this end, in addition to the Clínica Universidad Navarra, 8 other public and private institutions from Spain, France and Portugal, specialized in cardiology, cell therapy, nanotechnology, 3D printing, bioengineering and technology transfer, make up the project .  

"In Industry 4.0, 3D printing is used for prototyping, creating molds, tooling and for component customization. Many companies offering 3D printing services to industry may also be interested in providing their expertise and services to the healthcare sector. Strengthening synergies between these two sectors is core topic for European regions to develop stronger and better positioned economies," notes Itziar Gomez, manager of management of project.

This 'network of Excellence' will also promote close cooperation with the Public Administrations of the participating regions by implementing tools and services that will help to inform them of the latest medical advances in cardiac regenerative medicine and facilitate strategic decision making. At the same time, the project seeks to involve society with different informative actions on the advances at research and educational workshops.

All the entities of the consortium will meet on December 2 to start this project that will last three years. With this first virtual meeting , they will establish the instructions for the development of the research and will plan the work by annuities with the goal to reach, in approximately one year, its first milestone: to generate the different patch models and the first prototypes of 3D systems for the cultivation and transport of the patch and for the creation of the rollable model .

CARDIOPATCH is the second project that the University of Navarra, through the Clínica Universidad de Navarra, obtains as coordinator in the framework of the Interreg Sudoe Program. The first was GHELP, a personalized medicine project based on genomic diagnostic tools for the early detection of childhood hearing loss that has recently been recognized by the European Commission as one of the 30 most emblematic projects of the Interreg Initiative, which this year celebrates its 30th anniversary.