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


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.

SUBMITTER: Lener T 

PROVIDER: S-EPMC4698466 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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

Lener Thomas T   Gimona Mario M   Aigner Ludwig L   Börger Verena V   Buzas Edit E   Camussi Giovanni G   Chaput Nathalie N   Chatterjee Devasis D   Court Felipe A FA   Del Portillo Hernando A HA   O'Driscoll Lorraine L   Fais Stefano S   Falcon-Perez Juan M JM   Felderhoff-Mueser Ursula U   Fraile Lorenzo L   Gho Yong Song YS   Görgens André A   Gupta Ramesh C RC   Hendrix An A   Hermann Dirk M DM   Hill Andrew F AF   Hochberg Fred F   Horn Peter A PA   de Kleijn Dominique D   Kordelas Lambros L   Kramer Boris W BW   Krämer-Albers Eva-Maria EM   Laner-Plamberger Sandra S   Laitinen Saara S   Leonardi Tommaso T   Lorenowicz Magdalena J MJ   Lim Sai Kiang SK   Lötvall Jan J   Maguire Casey A CA   Marcilla Antonio A   Nazarenko Irina I   Ochiya Takahiro T   Patel Tushar T   Pedersen Shona S   Pocsfalvi Gabriella G   Pluchino Stefano S   Quesenberry Peter P   Reischl Ilona G IG   Rivera Francisco J FJ   Sanzenbacher Ralf R   Schallmoser Katharina K   Slaper-Cortenbach Ineke I   Strunk Dirk D   Tonn Torsten T   Vader Pieter P   van Balkom Bas W M BW   Wauben Marca M   Andaloussi Samir El SE   Théry Clotilde C   Rohde Eva E   Giebel Bernd B  

Journal of extracellular vesicles 20151231


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,  ...[more]

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