Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper
Thomas Lener,Mario Gimona,Ludwig Aigner,Verena Börger,Edit I. Buzás,Giovanni Camussi,Nathalie Chaput,Devasis Chatterjee,Felipe A. Court,Hernando A. del Portillo,Lorraine O'Driscoll,Stefano Fais,Juan M. Falcón-Pérez,Ursula Felderhoff-Mueser,Lorenzo Fraile,Yong Song Gho,André Görgens,Ramesh C. Gupta,An Hendrix,Dirk M. Hermann,Andrew F. Hill,Fred H. Hochberg,Peter A. Horn,Dominique P.V. de Kleijn,Lambros Kordelas,Boris W. Kramer,Eva-Maria Krämer-Albers,Sandra Laner-Plamberger,Saara Laitinen,Tommaso Leonardi,Magdalena J. Lorenowicz,Sai Kiang Lim,Jan Lötvall,Casey A. Maguire,Antonio Marcilla,Irina Nazarenko,Takahiro Ochiya,Tushar Patel,Shona Pedersen,Gabriella Pocsfalvi,Stefano Pluchino,Peter J. Quesenberry,Ilona G. Reischl,Francisco J. Rivera,Ralf Sanzenbacher,Katharina Schallmoser,Ineke Slaper-Cortenbach,Dirk Strunk,Torsten Tonn,Pieter Vader,Pieter Vader,Bas W.M. van Balkom,Marca H. M. Wauben,Samir El Andaloussi,Samir El Andaloussi,Clotilde Théry,Eva Rohde,Bernd Giebel +57 more
TLDR
In this paper, the authors summarize recent developments and the current knowledge of extracellular vesicles (EVs) and discuss safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application.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.read more
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Minimal information for studies of extracellular vesicles 2018 (MISEV2018) : a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines
Clotilde Théry,Kenneth W. Witwer,Elena Aikawa,María José Alcaraz,Johnathon D. Anderson,Ramaroson Andriantsitohaina,Anna Antoniou,Anna Antoniou,Tanina Arab,Fabienne Archer,Georgia K. Atkin-Smith,D. Craig Ayre,Jean Marie Bach,Daniel Bachurski,Hossein Baharvand,Hossein Baharvand,Leonora Balaj,Shawn Baldacchino,Natalie N. Bauer,Amy A. Baxter,Mary Bebawy,Carla Beckham,Apolonija Bedina Zavec,Abderrahim Benmoussa,Anna Berardi,Paolo Bergese,Ewa Bielska,Cherie Blenkiron,Sylwia Bobis-Wozowicz,Eric Boilard,Wilfrid Boireau,Antonella Bongiovanni,Francesc E. Borràs,Steffi Bosch,Chantal M. Boulanger,Chantal M. Boulanger,Xandra O. Breakefield,Andrew M. Breglio,Andrew M. Breglio,Meadhbh Á. Brennan,Meadhbh Á. Brennan,David R. Brigstock,David R. Brigstock,Alain Brisson,Marike L. D. Broekman,Marike L. D. Broekman,Jacqueline Bromberg,Paulina Bryl-Górecka,Shilpa Buch,Amy H. Buck,Dylan Burger,Sara Busatto,Sara Busatto,Dominik Buschmann,Benedetta Bussolati,Edit I. Buzás,Edit I. Buzás,James Bryan Byrd,Giovanni Camussi,David R. F. Carter,Sarah Caruso,Lawrence W. Chamley,Yu Ting Chang,Amrita Datta Chaudhuri,Chihchen Chen,Shuai Chen,Lesley Cheng,Andrew Chin,Aled Clayton,Stefano P. Clerici,Alex Cocks,Emanuele Cocucci,Robert J. Coffey,Anabela Cordeiro-da-Silva,Yvonne Couch,Frank A. W. Coumans,Beth Coyle,Rossella Crescitelli,Miria Ferreira Criado,Crislyn D'Souza-Schorey,Saumya Das,Paola de Candia,Eliezer F. De Santana,Olivier De Wever,Hernando A. del Portillo,Tanguy Demaret,Sarah Deville,Sarah Deville,Andrew Devitt,Bert Dhondt,Dolores Di Vizio,Lothar C. Dieterich,Vincenza Dolo,Ana Paula Domínguez Rubio,Massimo Dominici,Mauricio Rocha Dourado,Mauricio Rocha Dourado,Tom A. P. Driedonks,Filipe V. Duarte,Heather M. Duncan,Ramon M. Eichenberger,Karin M. Ekström,Samir El Andaloussi,Celine Elie-Caille,Uta Erdbrügger,Juan M. Falcón-Pérez,Farah Fatima,Jason E. Fish,Jason E. 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TL;DR: Clinically, EVs may be biomarkers and novel therapeutic targets for cancer progression, particularly for predicting and preventing future metastatic development.
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Extracellular Vesicles: Unique Intercellular Delivery Vehicles.
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