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dc.contributor.authorLener, Thomasen_US
dc.contributor.authorGimona, Marioen_US
dc.contributor.authorAigner, Ludwigen_US
dc.contributor.authorBörger, Verenaen_US
dc.contributor.authorBuzas, Editen_US
dc.contributor.authorCamussi, Giovannien_US
dc.contributor.authorChaput, Nathalieen_US
dc.contributor.authorChatterjee, Devasisen_US
dc.contributor.authorCourt, Felipe A.en_US
dc.contributor.authordel Portillo, Hernando A.en_US
dc.contributor.authorO'Driscoll, Lorraineen_US
dc.contributor.authorFais, Stefanoen_US
dc.contributor.authorFalcon-Perez, Juan M.en_US
dc.contributor.authorFelderhoff-Mueser, Ursulaen_US
dc.contributor.authorFraile, Lorenzoen_US
dc.contributor.authorGho, Yong Songen_US
dc.contributor.authorGörgens, Andréen_US
dc.contributor.authorGupta, Ramesh C.en_US
dc.contributor.authorHendrix, Anen_US
dc.contributor.authorHermann, Dirk M.en_US
dc.contributor.authorHill, Andrew F.en_US
dc.contributor.authorHochberg, Freden_US
dc.contributor.authorHorn, Peter A.en_US
dc.contributor.authorde Kleijn, Dominiqueen_US
dc.contributor.authorKordelas, Lambrosen_US
dc.contributor.authorKramer, Boris W.en_US
dc.contributor.authorKrämer-Albers, Eva-Mariaen_US
dc.contributor.authorLaner-Plamberger, Sandraen_US
dc.contributor.authorLaitinen, Saaraen_US
dc.contributor.authorLeonardi, Tommasoen_US
dc.contributor.authorLorenowicz, Magdalena J.en_US
dc.contributor.authorLim, Sai Kiangen_US
dc.contributor.authorLötvall, Janen_US
dc.contributor.authorMaguire, Casey A.en_US
dc.contributor.authorMarcilla, Antonioen_US
dc.contributor.authorNazarenko, Irinaen_US
dc.contributor.authorOchiya, Takahiroen_US
dc.contributor.authorPatel, Tusharen_US
dc.contributor.authorPedersen, Shonaen_US
dc.contributor.authorPocsfalvi, Gabriellaen_US
dc.contributor.authorPluchino, Stefanoen_US
dc.contributor.authorQuesenberry, Peteren_US
dc.contributor.authorReischl, Ilona G.en_US
dc.contributor.authorRivera, Francisco J.en_US
dc.contributor.authorSanzenbacher, Ralfen_US
dc.contributor.authorSchallmoser, Katharinaen_US
dc.contributor.authorSlaper-Cortenbach, Inekeen_US
dc.contributor.authorStrunk, Dirken_US
dc.contributor.authorTonn, Torstenen_US
dc.contributor.authorVader, Pieteren_US
dc.contributor.authorvan Balkom, Bas W. M.en_US
dc.contributor.authorWauben, Marcaen_US
dc.contributor.authorAndaloussi, Samir Elen_US
dc.contributor.authorThéry, Clotildeen_US
dc.contributor.authorRohde, Evaen_US
dc.contributor.authorGiebel, Bernden_US
dc.date.accessioned2016-02-01T15:45:52Z
dc.date.issued2015en_US
dc.identifier.citationLener, T., M. Gimona, L. Aigner, V. Börger, E. Buzas, G. Camussi, N. Chaput, et al. 2015. “Applying extracellular vesicles based therapeutics in clinical trials – an ISEV position paper.” Journal of Extracellular Vesicles 4 (1): 10.3402/jev.v4.30087. doi:10.3402/jev.v4.30087. http://dx.doi.org/10.3402/jev.v4.30087.en
dc.identifier.issn2001-3078en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:24983970
dc.description.abstractExtracellular 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.en
dc.language.isoen_USen
dc.publisherCo-Action Publishingen
dc.relation.isversionofdoi:10.3402/jev.v4.30087en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4698466/pdf/en
dash.licenseLAAen_US
dc.subjectimmunologyen
dc.subjectneurobiologyen
dc.subjecthaematologyen
dc.subjectstem cellsen
dc.subjecttissue regenerationen
dc.subjecttumour vaccinationen
dc.subjectregulationen
dc.titleApplying extracellular vesicles based therapeutics in clinical trials – an ISEV position paperen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalJournal of Extracellular Vesiclesen
dash.depositing.authorMaguire, Casey A.en_US
dc.date.available2016-02-01T15:45:52Z
dc.identifier.doi10.3402/jev.v4.30087*
dash.authorsorderedfalse
dash.contributor.affiliatedMaguire, Casey


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