The central nervous system has a limited capacity for self-repair. Therefore, technologies to replace lost neurons after an injury, including stroke or neurodegenerative diseases, are of great need. The project REGENERAR aims to develop a non-viral delivery formulation up to TRL4 for the delivery of a brain reprogramming formulation.
In the first step, the safety and targeting of the formulation will be tested in vitro.
In the second step, the in vivo safety, elimination, targeting and cell reprogramming will be evaluated. In addition, toxicological studies will be performed in GLP conditions to evaluate both in vivo systemic and local (brain) effects of the formulation.
The development of the non-viral formulation will take into account the contributions of key stakeholders in the area of gene editing, health institutions, and patient associations, among others. A roadmap will be developed for upscaling innovation to higher TRL.
REGENERAR WP1 will focus on the development and characterization of innovative non-viral formulation for brain cell reprogramming.
REGENERAR WP2 will focus on in vitro demonstration of safety, targeting and efficiency of the innovative non-viral formulations for brain cell reprogramming.
REGENERAR WP3 will study the best route of administration of the innovative non-viral formulations to achieve effective brain delivery.
REGENERAR WP4 will evaluate in vivo the efficiency of the innovative non-viral formulations for brain cell reprogramming.
REGENERAR WP5 will focus on the communication, dissemination and exploitation of project achievements.
REGENERAR WP6 focus on project coordination and management to ensure project’s objectives are achieved and that the Project is implemented in compliance with the EC Grant Agreement (GA) and Consortium Agreement (CA).
The consortium includes six partners from three European Member states, including two academic institutions (University of Coimbra, Portugal and Helmholtz Munich, Germany), one research institute (Fraunhofer-Gesellschaft, Germany), one biotech SME (Single Technologies AB, Sweden), one large company (Hovione Farmaciência S.A., Portugal) and one project management company (Sociedade Portuguesa da Inovação, Portugal).
Consortium partners have expertise in different fields, including brain drug delivery protein production and epigenome editing, production of nanoparticles under GLP conditions, spatially resolved transcriptomics, and safety and toxicity studies.
The research group has two main avenues of research:
The research group uses many tools to accomplish this goal, including the design of new biomaterials with relevant biological information, molecular and cell biology, microfluidic systems, high content analysis, and animal experimentation. Nanomedicine platforms to modulate the activity of stem cells and their progenies. The development of a wide spectrum of nanotechnologies (referred as Nanomedicine by National Institutes of Health for applications in the biomedical area) during the last years are very promising for the study of stem cell biology and to control exogenous and endogenous stem cells for regenerative medicine. The group is particularly interested to use these tools to induce in vivo stem cell differentiation and to mobilize stem cells from their niches to treat cardiovascular diseases. For this purpose, they are developing nanomaterials that release efficiently biomolecules (small molecules, proteins or non-coding RNAs) to manipulate stem cells or their progenies.
Coordinator of REGENERAR Project
Dr. Lino Ferreira is Coordinator Researcher at Faculty of Medicine, University of Coimbra, Portugal and vice-director of Associate Laboratory CIBB, the largest biomedical research lab in the center region of Portugal. His research is focus on the development of bioengineering tools to promote regeneration and reset ageing in the cardiovascular system. He holds a Ph.D. in Biotechnology from the University of Coimbra (Portugal). He did postdoctoral work at INEB (Portugal) and MIT (USA) in the areas of stem cells and nanotechnologies. He established his research group in 2008 at the University of Coimbra. In 2012, he was awarded with a prestigious European Research Council starting grant and in 2016 a prestigious ERA Chair position at the University of Coimbra. Outside the coordination of REGENEAR project, he likes to read, listen Jazz, watch tennis and run for pleasure.
MSc
Anna Anjo-Stefanidis completed her BSc in Biology with a specialization in Biomedical Science at York University in Toronto, Canada in 2022, followed by the completion of her Master’s degree in Cellular and Molecular Biology at the University of Coimbra in 2024. Anna’s focus has been on the development and delivery of polymeric nanoformulations to target cells for the purpose of cellular reprogramming and gene editing. Outside the lab, Anna’s interests include outdoor activities, reading, and spending time with family and friends.
Postdoctoral Research Associate
Phd
Artur Filipe Rodrigues earned his PhD in Nanoscience from the University of Manchester (UK) in 2019, following his MSc in Molecular Biotechnology from the University of Aveiro (Portugal) in 2014. He joined the group of Dr Lino Ferreira as a postdoctoral researcher in 2019, where he has developed nanoformulations for the delivery of biologics, including enzymes and mRNA, for gene editing in the brain and skin. Filipe is interested in exploring the physicochemical properties of nanomaterials to tailor their pharmacological properties for precise in vivo delivery. Outside the lab, Filipe enjoys playing the guitar, watching series, and listening to podcasts, in addition to spending time with his wife and two daughters.
MSc
Filipe Brás obtained a Bachelor’s degree in Biochemistry in 2021 and a Master’s degree in Clinical Biochemistry in 2023, both from the University of Aveiro (Portugal). During these two academic experiences, Filipe had the opportunity to engage with a range of research areas, including nanomedicine (for cancer treatment), molecular pathology and proteomics. Since April 2024, Filipe has been a research fellow dedicated to the REGENERAR project, under the supervision of Dr Lino Ferreira and Dr Filipe Rodrigues. His current research activities are focused on the synthesis and modification of nanoparticles for brain cell reprogramming. Outside of science, he enjoys spending time with friends and family, working out at the gym, watching movies/series, documentaries and travelling.
Senior Researcher
Phd
Luís Estronca has a Bachelor in Biochemistry from the University of Algarve and a PhD in Chemistry from the University of Coimbra (Portugal). After completing his PhD he did his 1st post-doc in Cell Biology to unravel the initial mechanism of atherosclerosis using macrophages and a oxidized lipoprotein model. In his 2nd post-doc, in Stem Cells and Nanomaterials, he joined Lino Ferreira’s group and worked with human iPSC to differentiate into smooth muscle and endothelial cells to develop in vitro vascular platforms for in vitro screenings. In the last years he has been worked as lab and project manager of an ERA Chair European project and more recently of a Twinning European project, both in the thematic of ageing. Outside the lab, he regularly practices swimming and football, he also is actively involved in basketball, as team director, and volleyball as being the sports that his son and daughter play. He enjoys spending time with friends and family.
MSc
Phd Student
With a background in Biochemistry, Joana Brito completed her Master’s degree in Pharmaceutical Biotechnology in 2023 and a postgraduate course in Biomedical Research in 2024, both at the University of Coimbra. She is pursuing her PhD in Health Sciences at the Faculty of Medicine of the University of Coimbra, focusing on the dissection of the molecular mechanisms underlying cellular reprogramming with spatial resolution in brain organotypic cultures. Outside the lab, Joana has been involved in volleyball since childhood, first as an athlete and now as a coach and referee. In her spare time, she enjoys playing music, watching movies, and spending time with her dogs, Kate and Harry. She also loves to travel and spend time with her family.
Since its inception, SPI has become a leading promoter of linkages between private sector companies, Science and Technology institutions, and National and International public and private organizations. From its onset, SPI embraced the mission of managing projects that promote regional, national and international development, stimulate entrepreneurship, innovation and knowledge management and encourage internationalization and creation of strategic partnerships and business relationships.
SPI has established a unique in-house capability that combines its knowledge of Innovation, Science and Technology with its fundamental skills in territorial planning and urban development. Since its creation in 1997, SPI was involved in the Leadership/Partnership in about 25 FP7 projects, 50 Horizon 2020 projects and 28 Horizon Europe projects and collaborated with more than 80 districts in Portugal, including setting local multi-actor forums.
Headquartered in Neuherberg in the north of Munich is the largest scientific organization in Germany with more than 40,000 employees at 19 research centers.
The Epigenetic Engineering group, lead by Prof. Dr. Stefan H. Stricker, investigate which mechanisms ensure that cells do not change identity during the lifetime and how we can manipulate those to freely convert cell fates. We employ a wide range of CRISPR methods to test in vitro and in vivo, which epigenetic marks and gene activities have functional relevance in mediating cell identity or disease phenotypes in the brain.
Professor
Dr. Stefan Stricker is group leader the Institute of Stem Cells at Helmholtz Munich and Professor at the Biomedical Centre of the Ludwig Maximilian University München. He studies the mechanisms ensuring that cells do not change identity and, how cells can be manipulated to freely convert and replace cellular fates. He employs a wide range of CRISPR methods in vitro and in vivo to correct gene activities and disease phenotypes in the brain.
MSc
Phd Student
Almudena Garcia Gomez-Monedero earned her MSc in Molecular and Cellular Biology from LMU München (Germany) in 2024, after completing her BSc in Biology at Imperial College (UK) in 2021. She joined the group of Prof. Dr. Stefan Stricker as a PhD student in 2024, where she studies neural fates and the mechanisms behind cell fate specification. She works on manipulating cell identity with the use of CRISPR ribonucleoproteins.
MSc
Phd Student
Nishant Chintalagiri earned his MSc in Molecular and Cellular Biology from Ludwig Maximilian University of Munich in 2024. During his master’s thesis at the Stricker lab within the Institute of Stem Cells at Helmholtz Munich, he investigated the influence of mRNA codon composition on stability and its downstream cellular effects. Now, as a PhD student in the same lab, he will be delving deeper into the potential for codon optimality-based manipulation of cell fate.
Over 60 years of experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites, USA, China, Ireland and Portugal, Hovione offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche generic API products. In the inhalation area, Hovione is the only independent company offering a complete range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. Hovione is a company with a culture based on innovation, quality and delivery.
Single Technologies is pushing the limits of genomics by combining single molecule imaging, fast large area confocal scanning, grating techniques, fluidics, nanotechnology. Our technology is being explored by leaders and industry in the genomics field who cares about Big Data generation.
Single Technologies was founded out of KTH research in single molecule imaging and biotechnology. Our prediction is an exponential increase of the need of sequenced data to enable the full potential of applying Big Data and AI to genetic analysis, in particular accurate diagnoses and personalized treatments, where Singe Technologie’s breakthroughs will play a major role enabling such progress.
CEO / Founder / Board Member
PhD
Johan drives the company’s vision to revolutionize life sciences through advanced 3-D imaging and sequencing technology. Under his leadership, the company has developed the world’s fastest 3-D imaging system and pioneered groundbreaking 3-D Sequencing technology. He has a strong academic background with an M.Sc. in Mathematics, an M.Sc. in Engineering Physics, and a PhD in Biological Physics from KTH Royal Institute of Technology. His research in single-molecule imaging and spectroscopy has laid the foundation for the technologies he now develops and commercializes.
Chief Genomics Officer
Phd
At Single Technologies, Xiang Jiao serves as the Chief Genomics Officer, where she leads the Application R&D team, overseeing the development of innovative 3-D Sequencing kits. Since joining the company in 2015, Xiang has been instrumental in driving research and development efforts that are shaping the future of DNA sequencing. She built a strong foundation with over 10 years of academic research in cancer genetics. Her work has been presented at top international conferences and contributed to the WHO Classification of Tumours series, reflecting her deep expertise in genomics. Xiang holds a B.Sc. in Biology from Fudan University, an M.Sc. in Applied Biotechnology, and a Ph.D. in Medical Science from Uppsala University. She also conducted postdoctoral research at the International Agency for Research on Cancer and Karolinska Institutet.
Interim CCO/Board Member
MSc, MBA
Steve Glavas serves as a Board Member at Single Technologies, where he leverages his extensive experience in sales and business development within the life sciences sector. In this role, he plays a pivotal part in guiding the company’s strategic direction and expanding its market reach. Throughout his career, he has held key positions such as VP of Sales and GM for EMEA at Celsee, Inc., and Sales Executive at 10X Genomics, where he also led Nordic and Benelux sales for single-cell analysis. Earlier, as Head of NGS at Sweden’s Institute for Communicable Disease Control, Steve developed a clinical NGS platform capable of handling diverse sample types. He also contributes his strategic insights as a board member for biotech companies like NEOGAP Therapeutics AB and CG Biology. Steve holds a Master’s Degree in Molecular Biology and an MBA from San Jose State University, as well as a Bachelor’s Degree in Molecular Biology with minors in Chemistry and Humanities from the same institution.
Currently the company operates 76 institutes and research units throughout Germany.
The Department of Inhalation Toxicology, lead by Dr Gustav Bruer offers a broad range of toxicological tests enabling assessment of potential risks to human health. Substances investigated include chemicals, particles, complex mixtures, and nanomaterials. The focus is on inhalation toxicology and on characterizing inhalable substances. Expertise ranges from the development and implementation of testing strategies to accompanying and providing consultancy to companies in registering their products. A sound basis for their work is provided by the institute’s expertise in inhalation, fiber and particle toxicology, and in aerosol research and chemical analysis.
Dr. Gustav Bruer (Head: Dept. of Inhalation Toxicology, Study director) studied veterinary medicine and got the approval as Veterinary Surgeon. He joined the Dept. of Inhalation Toxicology in 2021 and achieved a degree as Master of Laboratory Animal Science as well as board certified toxicologist. In the Dept. of Inhalation Toxicology, his main interest is focused on the investigation of effects of airborne materials on human health following inhalative uptake in the respiratory tract. Another focus of his research is the toxicological assessment of nanoparticles and their effects after distribution in the body, such as the brain.
Dr. Dirk Schaudien (Head: Dept. of Pathology) studied veterinary medicine and is an international board-certified veterinary pathologists (Diplomate of the American College of Veterinary Pathology) and a national certified veterinary pathologist and toxicopathologist. In his PhD-Thesis he has worked on neuropathologic changes after viral infection. His expertise covers all fields of diagnostic toxicologic pathology, especially inhalation toxicology and carcinogenicity studies in rodents.
MSc
Phd Student
Miriam Kryjewska studied Molecular Life Science at the University of Lübeck in the Bachelor’s program and deepened her knowledge in the field of neuroscience in the master’s program. After a brief stint in industry, she joined Dr. Gustav Bruer’s Department of Inhalation Toxicology in 2024 to conduct research in the field of neurotoxicology as part of a doctoral thesis. By participating in REGENERAR, she is fulfilling her dream of exploring the secrets of neuroendocrinology.
Dr. Annika Bach-Hagemann studied veterinary medicine. Afterwards she worked in basic research into stroke for five years and earned her doctoral degree from the RWTH Aachen University. Additionally, she completed a master’s degree in laboratory animal science. Since 2021 she works at Fraunhofer ITEM and since 2023 she is head of animal laboratory at Fraunhofer ITEM.