The aim of the  Card-EV Project is to develop new advanced therapy medicinal products (ATMPs) for the use in cardiology, specifically designed to treat cardiovascular diseases (CVDs). The project involves the preparation of next-generation GMP products for autologous and allogeneic applications, based on extracellular vesicles (EVs) secreted by two types of human stem cells (SCs) with reduced immunogenicity.  

Particularly, the goal of the Project is to generate genetically modified SCs with hypoimmunogenic properties, that will serve as stable donor cell lines producing EVs constituting the active substance of new ATMP products. Specifically, we will aim at develop two types of "off-the-shelf" products, based on EVs secreted by stable MSC or iPSC lines with well-defined reduced immunogenicity. Subsequently, several in vitro studies are planned to be performed in order to assess functional properties and stability of developed ATMP products, together with the development of quality control (QC) tests that are indispensable in the process of validation. Additionally, in vivo study on murine acute myocardial infarction (AMI) model will be also conducted to evaluate the pro-regenerative potential of prepared EV-based products. 

Importantly, preparation of GMP-compliant operating procedures of product preparation, characterization and formulation will be developed and optimized, which will allow further steps of products commercialization, including preparation of the clinical trial and finally, translation into the clinical practice. 

By addressing the critical demand for innovative CVD therapies, the project's results will deliver tangible social and economic benefits, delivering next-generation drugs in cardiology and thus contributing to the development of regenerative medicine.