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Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper

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Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper

dc.contributor.author	Lener, T.
dc.contributor.author	Gimona, M.
dc.contributor.author	Aigner, L.
dc.contributor.author	Börger, V.
dc.contributor.author	Buzas, E.
dc.contributor.author	Camussi, Giovanni
dc.contributor.author	Chaput, N.
dc.contributor.author	Chatterjee, D.
dc.contributor.author	Court, F.A.
dc.contributor.author	Portillo, H. A. del
dc.contributor.author	O'Driscoll, L.
dc.contributor.author	Fais, S.
dc.contributor.author	Falcon-Perez, J.M.
dc.contributor.author	Felderhoff-Mueser, U.
dc.contributor.author	Fraile, L.
dc.contributor.author	Gho, Y.S.
dc.contributor.author	Görgens, A.
dc.contributor.author	Gupta, R.C.
dc.contributor.author	Hendrix, A.
dc.contributor.author	Hermann, D.M.
dc.contributor.author	Hill, A.F.
dc.contributor.author	Hochberg, F.
dc.contributor.author	Horn, P.A.
dc.contributor.author	Marcilla Díaz, Antonio
dc.date.accessioned	2016-01-08T11:18:52Z
dc.date.available	2016-01-08T11:18:52Z
dc.date.issued	2015
dc.identifier.citation	Lener, T. Gimona, M. Aigner, L. Börger, V. Buzas, E. Camussi, Giovanni Chaput, N. Chatterjee, D. Court, F.A. Portillo, H.A. del O'Driscoll, L. Fais, S. Falcon-Perez, J.M. Felderhoff-Mueser, U. Fraile, L. Gho, Y.S. Görgens, A. Gupta, R.C. Hendrix, A. Hermann, D.M. Hill, A.F. Hochberg, F. Horn, P.A. Marcilla Diaz, Antonio 2015 Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper Journal of Extracellular Vesicles 4 30087
dc.identifier.uri	http://hdl.handle.net/10550/49866
dc.description.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
dc.language.iso	eng
dc.relation.ispartof	Journal of Extracellular Vesicles, 2015, vol. 4, p. 30087
dc.subject	Biologia experimental
dc.subject	Cèl·lules
dc.subject	Bioquímica clínica
dc.subject	Medicina Investigació
dc.title	Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper
dc.type	journal article	es_ES
dc.date.updated	2016-01-08T11:18:52Z
dc.identifier.doi	10.3402/jev.v4.30087
dc.identifier.idgrec	109089
dc.rights.accessRights	open access	es_ES