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Title: Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper
Author: Lener, Thomas
Gimona, Mario
Aigner, Ludwin
Borger, Verena
Buzas, Edit
Camussi, Giovanni
Chaput, Nathalie
Chatterjee, Devasis
Court, Felipe A.
Portillo Obando, Hernando A. del
O'Driscoll, Lorraine
Fais, Stefano
Falcón-Pérez, Juan M.
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
Assaigs clínics
Stem cells
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:
It is part of: Journal of Extracellular Vesicles, 2015, vol. 4, num. 30087, 31 p.
Related resource:
ISSN: 2001-3078
Appears in Collections:Articles publicats en revistes (ISGlobal)

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