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Title: | Applying extracellular vesicles based therapeutics in clinica trials - an ISEV position paper |
Author: | Lener, Thomas Gimona, Mario Aigner, Ludwig Borger, Verena Buzas, Edit I. Camussi, Giovanni Chaput, Nathalie Chatterjee, Devasis Court, Felipe A. Portillo Obando, Hernando A. del O'Driscoll, Lorraine Fais, Stefano Falcón Pérez, Juan Manuel Felderhoff-Mueser, Ursula Fraile, Lorenzo Gho, Yong Song Gorgens, André Gupta, Ramesh C. Hendrix, An Hermann, Dirk M. Hill, Andrew F. Hochberg, Fred Horn, Peter A. Kleijn, Dominique de Kordelas, Lambros Kramer, Boris W. Kramer-Albers, Eva-Maria Laner-Plamberger, Sandra Laitinen, Saara Leonardi, Tommaso Lorenowicz, Magdalena J. Lim, Sai Kiang Lötvall, Jan Maguire, Casey A. Marcilla, Antonio Nazarenko, Irina Ochiya, Takahiro Patel, Tushar Pedersen, Shona Pocsfalvi, Gabriella Pluchino, Stefano Quesenberry, Peter Reischl, Ilona G. Rivera, Francisco J. Sanzenbacher, Ralf Schallmoser, Katharina Slaper-Cortenbach, Ineke Strunk, Dirk Tonn, Torsten Vader, Pieter Balkom, Bas W. M. van Wauben, Marca H. M. Andaloussi, Samir El Thery, Clotilde Rohde, Eva Giebel, Bernd |
Keywords: | Cèl·lules mare Immunologia Neurobiologia Hematologia Assaigs clínics Stem cells Immunology Neurobiology Hematology Clinical trials |
Issue Date: | 31-Dec-2015 |
Publisher: | Co-Action Publishing |
Abstract: | Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed. |
Note: | Reproducció del document publicat a: http://dx.doi.org/10.3402/jev.v4.30087 |
It is part of: | Journal of Extracellular Vesicles, 2015, vol. 4, num. 30087, 31 p. |
URI: | http://hdl.handle.net/2445/69165 |
Related resource: | http://dx.doi.org/10.3402/jev.v4.30087 |
ISSN: | 2001-3078 |
Appears in Collections: | Articles publicats en revistes (ISGlobal) |
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