Consortium is composed of:

  • academic and research centres: FTELE, IQS, UNAV, SQ, UHREG
  • hospitals: OSR, IGTP, UNAV
  • SMEs: ASP, SRI, ADEMTO, INN-Acta

from five EU countries (Italy, Spain, Netherlands, Hungary, Germany).

Silvia Gregori
Expertise, Role and Activity

Silvia Gregori is the Head of the Mechanisms of Peripheral Tolerance Unit at San Raffaele Telethon Institute for Gene Therapy).  She has extensive experience in the implementation and management of regional, national, and international multidisciplinary projects, both as a partner and as coordinator.
Dr. Gregori’s expertise is mainly in research on tolerogenic dendritic cell, their role in modulating immune responses, and their use as a therapy to prevent/control adverse immune responses. She made pioneer work in studying the role of VitD3 and its analogues in transplantation tolerance and in preventing autoimmune disorders.

FTELE (leader of WP1 and 3 & partner in WP2, WP4, WP5, WP7 and WP8) and its affiliated entity OSR have long-standing experience in translating proof-of-concept studies into gene therapy clinical trials, having treated more than 120 patients and collaborating with industrial partners.
In IMMUTOL Silvia Gregori’s team provides pioneering contributions to the gene and cell therapy field and brings expertiese in immunological tolerance, tolerogenic dendritic cells, regulatory T cells, IL-10, lentiviral vector gene transfer.

Giada Amodio

Giada Amodio is a Postdoctoral fellow in Silvia Gregori’s team. Her work mainly focused on immunological tolerance,  she investigated the presence and the role of IL-10-producing tolerogenic dendritic cells in healthy and autoimmune diseases. She also characterized the modulatory activity of IL-10 genetically engineered tolerogenic dendritic cells.
She will be involved in optimizing the differentiation protocol to obtain VitD3DCIL-10 cells, defining their potency and modulatory activity in WP3. She will also participate in the development of quality control assays for the production of VitD3IL-10 cells, WP3 and WP5.

Gloria Giacomello

PhD student Gloria Giacomello, graduated in Molecular Biotechnology at the University of Torino with a strong background in Immunology. As Research Assistant in the Gregori’s lab, she was involved in a project aimed on dissecting the role of DC-10 in dampening the unwanted immune response in the context of autoimmune diseases and graft-versus-host disease. She will be involved in developing, and  characterising VitD3DCIL-10 cells in Wp3 and WP4.

Laura Passerini

Staff Scientist, Laura Passerini  has expertise in studies of regulatory cell phenotype and function in health and disease, especially in patients with immune dysregulation and autoimmunity; development of cell therapies with genetically engineered regulatory cells for the control of autoimmune disorders. She will have a key role in designing of lentiviral vectors for the engineering of VitD3 tolerogenic DC and optimization of protocols for the generation of 2nd generation of VitD3 DC in WP3 and WP4.

Grazia Adinolfi

Grazia Andolfi (Senior Technician) in the team, has long lasting experience in generating and characterizing tolerogenic cells, in vector production and optimization of protocols for cell differentiation. She will provide technical support for the generation and characterization of 2nd generation of VitD3 DC in WP3 and WP4.

Francesca Santoni De Sio

Francesca Santoni De Sio is a Staff Scientist in Silvia Gregori’s team. She has been trained by leaders in the field of gene transfer and, at the beginning of her career, has optimized and validated lentiviral vector-based gene transfer protocols into human hematopoietic cells. She has later contributed to the definition of the genetic and epigenetic mechanisms controlling differentiation and function of immune cells. She has recently identified novel molecular pathways controlling tolerogenic DC differentiation. She will contribute to the characterization of patients’ derived monocytes and second generation VitD3 DC.

The research group at IGTP led by Prof. Martinez-Caceres  (leader of WP4 & partner in WP2, WP3, WP5, WP6, WP7, WP1 and WP8) is a multidisciplinary team  (with neurologists, pharmacists, biologists, biotechnologists and clinical immunologists) that brings to IMMUTOL expertise in translational Research, (from basic in vitro and in vivo- experimental autoimmune encephalomyelits-  preclinical studies to clinical application), in the field of multiple sclerosis. The group has developed a tolerogenic cellular product consisting of autologous monocyte-derived VitD3-tolerogenic dendritic cells, loaded with a pool of myelin peptides to treat MS patients. This therapy has been translated to the clinic in a Phase I clinical trial in active MS patients (Clinicaltrial.gov NCT02903537) using intranodal injection. Recently, the Phase II trial has been approved by the Spanish Regulatory Agency (AEMPS).

EVA MARTINEZ CACERES

Eva Martínez-Cáceres, MD PhD, is the Head of the Immunology Division at the central laboratory, Nord Metropolitan Area of Barcelona (LCMN), Germans Trias i Pujol Hospital (HUGTP), and Professor of Immunology at the Department of Cell Biology, Physiology, and Immunology at the Universitat Autònoma Barcelona (UAB). Eva is PI coordinator of the Immunopathology group at IGTP.  

Prof. Martínez-Cáceres research focuses on the analysis of immunological mechanisms of peripheral tolerance and development of cell-based tolerogenic therapies. She has coordinated the European COST ACTION- AFACTT (“Action to focus and accelerate cell-based tolerance-inducing therapies” –www.cost.eu-).  

CRISTINA RAMO-TELLO

CRISTINA RAMO-TELLO, MD PhD, is the Head of the Neuroimmunology and Multiple Sclerosis Unit at the Nord Metropolitan Area of Barcelona, Germans Trias i Pujol Hospital (HUGTP). She has a longstanding experience in the design and development of cellular therapy clinical trials, with a particular emphasis on mesenchymal cells (CELLTRIMS Trial) and tolDC (Tolervit-MS and RESTORE trial). She will be participating in IMMUTOL in in the recruitment of MS patients (WP3 and WP4) and in the future design of a clinical trial with engineered VitD3DC (WP6).

SILVIA PRESAS RODRIGUEZ

SILVIA PRESAS RODRIGUEZ, MD PhD, neurologist at the Multiple Sclerosis Unit in HUGTP, and member of the Immunopathology group at IGTP. She has contributed to several research lines, focused on the search for biomarkers of treatment response in MS, the treatment of MS relapse and the development of the phase I clinical trial with VitD3tolDC (RESTORE). She will participate in the recruitment of MS patients (WP3 y WP4) and the design of a future clinical trial with engineered vitD3DC (WP6).

AINA TENIENTE-SERRA

AINA TENIENTE-SERRA, PhD, staff immunologist at the Immunology Division, HUGTP-LCMN, and member of the Immunopathology group at IGTP. She contributed to the preclinical development of the first generation VitD3tolDC (IMPD) and to the immune monitoring of RESTORE (by whole blood flow cytometry). She will participate in preclinical studies with engineered VitD3DC and in the definition of the release criteria of the cellular product (WP4 and 5). 

FEDERICO FONDELLI

FEDERICO FONDELLI: Postdoctoral researcher of IMMUTOL. He graduated in Biology from the University of Florence and obtained a Marie Curie ITN PhD fellowship to conduct his doctoral thesis in the multiomic characterization of monocytes, VitD3tolDC and mature DC from MS patients and controls. He has experience in biomarker research through multiomic characterization of immune cells through spectral flow cytometry, bulk and single cell NGS technologies. ROLE: In vitro and ex vivo characterization of the mechanism of 1st and 2nd generation VitD3-tolDC through single-cell techniques (WP4), and definition of release criteria of the cellular product (WP5).

JANA WILLEMYNS

JANA WILLEMYNS.  PhD Student of IMMUTOL. She graduated in Biochemistry & Biotechnology from the University of Antwerp. She has experience with experimental autoimmune encephalomyelitis (EAE) in mice, a well-known animal model of MS, which will be used to assess the efficacy of the engineered VitD3DC product and define its off-target activity (WP4). She will also contribute to the myelin peptide selection for the generation of Ag-specific engineered VitD3DC (WP3).

CAGLA AKAGUNDUZ GULER

CAGLA AKAGUNDUZ GULER: PhD Student of IMMUTOL: She graduated from Heinrich-Heine University in Düsseldorf focusing on pharmacogenomic drug identification for Multiple Sclerosis as her Master’s study. She continued to do drug identification in some of the leading pharmaceutical companies in Germany, and afterwards she worked as a research associate on NGS technologies. She has a strong background on cellular neuroscience, as well as in vivo and in vitro studies. During her PhD in IMMUTOL she will contribute to analyze the in vivo mode of action of engineered VitD3DC compared to VitD3DC (WP4).

ALEX AGUNDEZ-MORENO

ALEX AGUNDEZ-MORENO: PhD student of IMMUTOL. Graduated in Biotechnology at the University of Girona (UdG) (BSc) and Advanced Immunology at the University of Barcelona and Autonomous University of Barcelona (MSc). As a PhD student of IMMUTOL, he will be involved in assessing the migratory potential of VItD3DC and lymphocytes co-cultured with them, using a dynamic model of BBB (WP4). He will also participate in myelin peptides selection for the generation of Ag-specific engineered VitD3DC (WP3).

BERTA ARCOS-RIBAS

BERTA ARCOS-RIBAS, technician in Eva Martinez-Cáceres group. She graduated in Human Biology in Pompeu Fabra University (BSc) and Advanced Immunology in University of Barcelona and Autonomous University of Barcelona (MSc). She will provide general technical support in the project, mainly focused in myelin peptides selection for the generation of Ag-specific engineered VitD3DC (WP3) and in vivo mode of action of engineered VitD3DC compared to VitD3DC (WP4).

MIRIAM SAN JOSÉ CASCÓN

MIRIAM SAN JOSÉ CASCÓN, staff immunologist at the Immunology HUGTP-LCMN, and member of the Immunopathology group at IGTP. She will be responsible of the interaction between the clinical and basic teams, promoting collaboration and information exchange.  Furthermore, she will be involved in data management and research findings dissemination ensuring strict compliance with ethical standards.

Anja ten Brinke
Expertise, Role and Activity

Anja ten Brinke is Project coordinator and scientific advisor Immunomonitoring Services (SQ) and Group leader at department of Immunopathology, subgroup Immune modulation and immunomonitoring at SQ.

Marieke van Ham

Marieke van Ham is a Professor of Biological Immunology, Swammerdam Institute for Life Sciences, Faculty of Science, University of Amsterdam and Head department of Immunopathology SQ.

Ten Brinke, PhD and Prof. Van Ham have extensive expertise in pre-clinical and clinical immune monitoring to study the mode of action of therapeutics.

The team at SQ (partner in WP3, WP4, WP5, WP1 and WP8) besides analyzing effects on T cells, is the lead in studying human B cell differentiation. They bring expertise in functional T and B cell assays, antigen-specific T cell analysis, MHCII multimers, in vitro B cell differentiation, DC-T cell cocultures, B- T cell cocultures, immunomonitoring, multi-colour flowcytometry and image stream analysis.

James Hutchinson
Expertise, Role and Activity

Prof. Hutchinson is a Group leader at UHREG. He is translational immunologist with interests in reestablishment of allograft intrinsic regulation, human macrophages, drug screening and predictive modelling.

Ralf Linker

© AMSEL e.V.  Martin Stollberg

Prof. Dr. Linker is Head of Neurology at UHREG where the focus is on the diagnosis and treatment of neurological emergency medicine and stroke care as well as as neuro-oncology and neuroimmunology with a particular focus on multiple sclerosis.

Stefanie Haase
Gunther Glehr
Lena Scheibert

UHREG is one of the main academic hospitals in Bavaria, and one of the most modern and efficient hospitals in Germany, delivering state-of-the-art treatment for complex medical and surgical cases. UHREG maintains an internationally competitive scientific program that prioritizes research in Oncology, Transplantation, and Immunotherapy.

The team at UHREG (leader of WP2 & partner in WP3, WP4, WP5, WP1 and WP8) provides expertise in regenerative and immunotherapeutic treatments, cell-based therapies, transplant immunology and immunosuppressive therapy.

More specifically, as a transplant immunologist, Prof. Hutchinson main focus will be on studying human regulatory macrophages (Mreg), being involved in clinical trials of Mreg therapy in KTx, leucapheresis and process-controls and immune monitoring. Gunther Glehr, PhD is a computational scientist, who’s research will be focused on classification of problems in diagnostic, mining flow cytometry and scRNA data, neural networks and application of computational tools to immune monitoring. Lena Scheibert, PhD as a clinician-scientist and expert in visceral surgery will work with assaying T cell responses in vitro and with IL-10-producing T cells from MS patients. Prof. Dr. Linker is a clinician-scientist and neuroimmunologist. He will dedicate his time for working on immunometabolism & neuroimmunology aspects of the project, together with Stefanie Haase, PhD. Dr. Linker will work on macrophage biology and will be involved in clinical trials in MS. More specifically Stefanie will focus on T cell and macrophage assays and flow cytometry.

Felipe Prosper Cardoso
Susana Inogés Sancho
Ascensión López Díaz de Cerio
Expertise, Role and Activity

Prof. Felipe Prósper is the Head of Cellular Therapy Unit and Co-director of Haematology and Haemotherapy Unit Haematology and Oncology Specialist.

It develops a research program and clinical application in cell therapy with adult stem cells, promoting several research lines, mainly focused on the use of stem cells for the treatment of cardiovascular, osteoarticular and immune diseases.

UNAV is a private hospital renowned for its high specialization degree, technological innovation, and teamwork, which allows for a personalized, multidisciplinary approach for each patient.

In IMMUTOL the UNAV team (leader of WP5 & partner in WP3, WP4, WP5, WP1 and WP8) including Dr. Susana Inogés Sancho and Dr. Ascensión López Díaz de Cerio provides expertise in development and manufacturing of advanced therapy products in GMP conditions, in the design, start up and conduct of clinical trials based on ATMP, including preparation of IMPD (Investigational Medicinal Product Dossier) for the future submission to regulatory agencies.

Jordi Martorell López
Expertise, Role and Activity

Dr. Jordi Martorell is the Head of Vascular Engineering and Applied Biomedicine at IQS. He has elucidated the mechanisms of flow-endothelial mechano-transduction in several vascular beds, including the BBB, coronary and carotid bifurcations, and the aorta. As a co-founder of Aortyx, a spin-off from IQS, he has gained increasing leverage in the implications of transferring lab discoveries into actual medical products.

The team at IQS (partner in WP4, WP5, WP7, WP1 and WP8) provides an unique model for blood brain barrier, fluid dynamics, tissue engineering, in vitro models.

Mercedes Balcells

Dr. Mercedes Balcells is a Principal Research Scientist at MIT’s Institute for Medical Engineering and Science and Profesora Titular in Bioengineering at Institut Químic de Sarrià. Her research in tissue engineering has shown how endothelial cell states are critical to tissue response to injury. She was the first to show that cells respond to flow frequency not just shear stress and in a manner which is tissue bed dependent. Dr. Balcells’ group has developed novel culture methods and perfusion systems that enable patient-specific geometrical parameters to tissue response. Those methods have been used to characterize cellular response to medical devices and pharmaceutical formulations in collaboration with industry. 

Sara Fuentelsaz Romero

Dr. Sara Fuentelsaz is a Postdoctoral fellow in Vascular Engineering and Applied Biomedicine group at IQS, under the supervision of Dr. Jordi Martorell. She possesses an extensive background in the realm of the immune system and autoimmune disorders, with a specific focus on innate immune tolerance and macrophages biology.

She will be involved in pre-clinical assays to study T cell recruitment into the central nervous system (CNS) during neuroinflammation, part of WP4. This will be achieved by implementing a three-dimensional (3D) culture model that incorporates a matrix designed to replicate the conditions of the blood-brain barrier (BBB) in vitro. The system mimics the structural and functional properties of the BBB, wherein human brain cortex astrocytes are embedded in a collagen-based hydrogel. This approach enables the investigation of cellular adhesion to the BBB endothelium as well as the study of migration towards the CNS.

Oriol Penon
Núria Coderch
Ester Cantó
Expertise, Role and Activity

Oriol Penon, PhD is Business Innovation Director. ASP is a Scientific and Regulatory Affairs consultancy company and offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages.

ASP (lead of WP6 & partner in WP2, WP3, WP5, WP7, WP1 and WP8) bring in valuable expertise in regulatory affairs, ATMPs, development of cell therapy, transition from pre-clinical to clinical research, engagement with authorities and regulatory document submission.
In the ASP IMMUTOL team Núria Coderch (Scientific and Regulatory Affairs Director) holds a PhD in Pharmacy and has 20 years of experience as Regulatory Affairs Executive Consultant,  especially in Regulatory Strategy and Drug Development, Medical and Scientific writing (for registration dossiers and clinical trials(IMPD, IB, CTA..)), meetings with regulatory agencies (EMA, National Agencies, FDA..), Orphan drug designations and Paediatric Investigational Plans (PIP / iPSP), and she is an expert in Small Molecules, Repurposing, Innovative, Biological / Biotechnological, and Advanced Therapy Medicinal Products (ATMPs) and Vaccines. She has participated in several FP7, H2020 and HORIZON projects.
Ester Cantó (Scientific and Regulatory Affairs Officer), holds a PhD in immunology and has experience in Medical and Scientific writing (for registration dossiers and clinical trials) and other regulatory procedures.

Rok Hren
László Szilberhorn
Janos Pitter
Expertise, Role and Activity

Rok Hren, PhD, MSc IHP (HE) is working as a Researcher at SRI (Hungary) and he is a  Research Assistant Prof. at the University of Ljubljana (Slovenia). He has more than 15 years of commercial experience in the pharmaceutical industry, with more than 12 years on a board level in both line management and leadership regional functions. His research interests include health economics, medical optics, and quantitative electrocardiography. Between 2018 and 2021, he served as a Director on the Board of Directors of ISPOR (The Professional Society for Health Economics and Outcomes Research, USA) as well as a member of the ISPOR Health Science Policy Council Science and Research Committee.

Scientists at SRI are experts in interfacing clinical research and economic evaluation and have published widely in the area. The company has special expertise in developing economic models and applying those models to substantiate policy decisions.

SRI (lead of WP7 & partner in WP6, WP1 and WP8) will contribute to IMMUTOL with their extensive experties in health economics, health policy, modelling, pricing & market access, net present value and multiplicative financing.

Furthermore the SRI IMMUTOL team includes Balázs Nagy, head of Modelling Division; László Szilberhorn, senior modeller and János G. Pitter, head of European Collaborative Research department.

Natascia Cannella
Gabriella Dessole
Kinga Zor
Simona Farnetani
Expertise, Role and Activity

Natascia Cannella is the CEO and Sole Administrator of INN-Acta, specialised in administration, financing and project management.

INN-Acta (lead of WP8 and support in WP1) provides expertise in project & grant management, EC funding, communication, website and events organization, networking, and access to collaboration database build in several years of activity.
INN-Acta will support the coordinator and the consortium in the management of administrative tasks of the project and communication activities.

In the INN-Acta team, Gabriella Dessole, is a Grant Manager with a strong scientific background, outstanding track record and expertise in managing EC funded projects, communication and event organization.

Kinga Zor (Grant Manager) is experienced in EU project writing and management with long track record in academic research in area of life science and engineering.
Simona Farnetani is a Communication & Events Manager, and she will provide valuable support in meeting organization. The IT team will be responsible for development and maintenance of the project website.

Silvia Torres Vicente Ruiz
Alicia Martínez Medina
Expertise, Role and Activity

Silvia Torres Vicente Ruiz is the Director of ADEMTO .

ADEMTO is a patient’s association, funded by a patient of multiple sclerosis to cover the rehabilitative treatment gap of the national health system and provide full rehabilitation to patients of multiple sclerosis and any other neurological disease.

In IMMUTOL, Silvia Torres Vicente Ruiz and Alicia Martínez Medina, physiotherapist and interdisciplinary team coordinator from ADEMTO will have an important role in organization of workshops, events for patients and programs with policymakers and private donors.