Researchers from Fraunhofer ITEM are contributing to toxicological studies on novel nanoparticle-based formulations within an EU project.

EU project REGENERAR: 3 million euros allocated for research into the development of innovative technologies for brain regeneration

News /

With the aim of developing a new technology for brain regeneration, the EU project REGENERAR kicks off on March 22, 2024. Fraunhofer ITEM is one of seven research partners, led by the University of Coimbra, seeking to create better therapies for patients with neurodegenerative diseases or stroke using this technology.

© Fraunhofer ITEM
The team from the University of Coimbra (from left to right) Filipe Rodrigues, Lino Ferreira, leader of the consortium, Luís Estronca, and Francesca Tomatis with Gustav Bruer (2nd from the right), who leads the team at Fraunhofer ITEM.

Over the next four years, a European research consortium, led by the University of Coimbra, will develop an innovative technology that could boost the regeneration of neurons in diseases that currently have limited therapeutic options. To do this, the scientists will use epigenetic tools to try to convert brain cells in patients into functional neurons. This research could pave the way for improved treatment of health problems such as stroke or neurodegenerative diseases, i.e. pathologies that are linked to the nervous system, affecting movement and causing loss of neurological functions.

The research project REGENERAR will be funded with around three million euros by the European Commission, more specifically by the European Innovation Council under the Pathfinder Open program, which funds interdisciplinary projects that open doors to innovative technological breakthroughs. The project is led by the researcher Lino Ferreira from the University of Coimbra Faculty of Medicine, the Center for Neuroscience and Cell Biology (CNC-UC) and the associated laboratory Center for Innovative Biomedicine and Biotechnology (CIBB).

The team at Fraunhofer ITEM will conduct toxicological studies

As part of the EU project REGENERAR – Improving the Effectiveness and Safety of Epigenetic Editing in Brain Regeneration –, the team at Fraunhofer ITEM, led by Dr. Gustav Bruer, will conduct toxicological studies for the new nanoparticle-based formulation in order to provide an initial assessment of its toxicological profile. This will include consideration of histopathology, neurotoxicity, and metabolism.

Creating alternatives to replace lost neurons

In general terms, REGENERAR aims to use epigenetic tools to reprogram certain brain cells into neurons. Basically, it uses what the human body already has, manipulating cells that have increased in number after the disease process, and transforming them into neuronal cells that are very important for brain function. In the case of the pathologies focused on in this research, Lino Ferreira explains: “The central nervous system has minimal capacity for self-repair, and it is necessary to create alternatives to replace neurons lost as a result of injury, as happens, for example, in stroke or neurodegenerative diseases.”

For stroke – which affects more than 15 million people worldwide every year and often causes significant limitations in routine activities such as walking or speaking – for example, current treatments have focused on restoring blood flow to minimize tissue damage, and there are no approved pharmacological treatments that promote brain repair. Thus, recognizing these therapeutic limitations, this European consortium hopes to open a new path for the treatment of stroke and neurodegenerative pathologies by designing a nanoparticle formulation in the laboratory that could, in the future, reach clinical practice. “This project stems from the vast experience of the University of Coimbra, and in particular of the Advanced Therapies group affiliated with the Faculty of Medicine and CNC-UC/CIBB, in the development of advanced formulations for the treatment of brain diseases,” says the researcher. Under the scope of this project, the team will conduct several rigorous safety tests, using advanced in-vitro models, as well as in-vivo toxicological studies, in accordance with good laboratory practices, to analyze the effectiveness of epigenetic reprogramming for clinical use. The scientists hope that this new technology can be validated in the laboratory by February 2028.

Six partners combine their expertise

The project partners include six academic and industrial institutions: the University of Coimbra (Portugal) The University of Coimbra, the Helmholtz Center in Munich (Germany), the Fraunhofer Institute for Toxicology and Experimental Medicine (Germany), Single Technologies AB (Sweden), the pharmaceutical company Hovione Farmaciência SA (Portugal) and Sociedade Portuguesa de Inovação (Portugal). At the same time, national and European health organizations and patient associations will also be involved in the project to create a strategy for the future translation of this innovative technology into clinical practice.