From Lab to Industry: Advancing the Translational Potential of Extracellular Vesicles Through the ISEV Translation, Regulation and Advocacy Committee (ISEV-TRA)

Fecha de publicación: 01/01/2026

Autores de IIS La Fe

Antonio Marcilla Díaz

Autor

Participantes ajenos a IIS La Fe

Gurriarán-Rodríguez, U.
Bussolati, B.
Gimona, M.
Glebov, K.
Fujita, Y.
Néri, C.
Fu, Q.-L.
Das, S.
Pluchino, S.
Zarovni, N.
Salomon, C.
Witwer, K.
Falcón-Pérez, J.M.

Grupos

Unidad Mixta de Investigación en Endocrinología, Nutrición y Dietética clínica

Abstract

Extracellular vesicles (EVs) have emerged as powerful mediators of intercellular communication with significant potential across biomedical, veterinary, cosmetic, agricultural and environmental applications. However, the translation of EV-based discoveries into practical and commercially viable products remains constrained by scientific complexity, regulatory uncertainty and manufacturing challenges. To address these barriers, the International Society for Extracellular Vesicles (ISEV) established the Translation, Regulation and Advocacy Committee (ISEV-TRA). ISEV-TRA aims to catalyse the responsible advancement of EV technologies by fostering cross-sector collaboration, harmonising quality and regulatory frameworks and providing strategic advocacy to enhance market readiness. Through targeted initiatives—such as workshops and the development of translational resources and guidance—ISEV-TRA seeks to bridge the gap between research and real-world implementation. By promoting dialogue amongst academia, industry, investors and policymakers, ISEV-TRA positions itself as a central driver in shaping the global roadmap for EV translation and commercialisation. © 2026 The Author(s). Journal of Extracellular Vesicles published by Wiley Periodicals, LLC on behalf of the International Society for Extracellular Vesicles.

Datos de la publicación

ISSN/ISSNe:: 2001-3078, 2001-3078
Tipo:: Editorial Material
Páginas:: -
DOI:: 10.1002/jev2.70220
PubMed:: 41531372
Enlace a otro recurso:: www.scopus.com
Factor de Impacto:: 4,878 SCImago ℠
Cuartil:: Q1 SCImago ℠

Documentos

Published Version

Métricas

Filiaciones

Gurriarán-Rodríguez, U.:: Exosomes Laboratory, CIC BioGUNE, Derio, Biscay, Spain
Bussolati, B.:: Università degli Studi di Torino, Scuola di Medicina, Turin, TO, Italy
Gimona, M.:: GMP Unit, Paracelsus Medizinische Privatuniversitat, Salzburg, Salzburg, Austria

Research Program Nanovesicular Therapies, Paracelsus Medizinische Privatuniversitat, Salzburg, Salzburg, Austria

Ludwig Boltzmann Institutes, Vienna, Austria
Glebov, K.:: Exosome Consulting, Bayreuth, Germany

School of Medicine, Faculty of Health, Plymouth, Devon, United Kingdom
Fujita, Y.:: Division of Next-Generation Drug Development, The Jikei University School of Medicine, Tokyo, Japan
Marcilla, A.:: Àrea de Parasitologia, Universitat de València, Valencia, Valencia, Spain

Instituto de Investigación. Nutrition and Clinical Dietetics, Instituto de Investigación Sanitaria La Fe, Valencia, Spain
Néri, C.:: Sorbonne Université, Paris, Ile-de-France, France
Fu, Q.-L.:: Otorhinolaryngology Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China

Extracellular Vesicle Research and Clinical Translational Center, Sun Yat-Sen University, Guangzhou, Guangdong, China

Center for Stem Cell Biology and Tissue Engineering, Sun Yat-Sen University, Guangzhou, Guangdong, China
Das, S.:: Cardiovascular Research Center, Massachusetts General Hospital, Boston, MA, United States
Pluchino, S.:: Department of Clinical Neurosciences, Cambridge, Cambridgeshire, United Kingdom
Zarovni, N.:: NEXUS project Day One srl, Rome, Italy

RoseBio Srl, Milan, Italy
Salomon, C.:: Translational Extracellular Vesicles in Obstetrics and Gynae-Oncology Group, UQ Centre for Clinical Research, Brisbane, QLD, Australia

UQ Centre for Extracellular Vesicle Nanomedicine, The University of Queensland, Brisbane, QLD, Australia
Witwer, K.:: Johns Hopkins University School of Medicine, Baltimore, MD, United States
Falcón-Pérez, J.M.:: Exosomes Laboratory, CIC BioGUNE, Derio, Biscay, Spain

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Madrid, Spain

Ikerbasque, Basque Foundation for Science, Bilbao, Basque Country, Spain

Keywords

circulating free DNA; monoclonal antibody; biological therapy; Editorial; European Medicines Agency; evidence based practice; exosome; Food and Drug Administration; gene therapy; good laboratory practice; good manufacturing practice; human; implementation science; International Society for Extracellular Vesicle Translation Regulation and Advocacy Committee; medical society; practice guideline; professional standard; reproducibility; stakeholder engagement; total quality management; translational research; animal; metabolism; Animals; Extracellular Vesicles; Humans; Translational Research, Biomedical

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