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Applying extracellu...
Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper.
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Lener, Thomas (author)
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Gimona, Mario (author)
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Aigner, Ludwig (author)
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show more...
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Börger, Verena (author)
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Buzas, Edit (author)
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Camussi, Giovanni (author)
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Chaput, Nathalie (author)
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Chatterjee, Devasis (author)
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Court, Felipe A (author)
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Del Portillo, Hernando A (author)
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O'Driscoll, Lorraine (author)
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Fais, Stefano (author)
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Falcon-Perez, Juan M (author)
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Felderhoff-Mueser, Ursula (author)
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Fraile, Lorenzo (author)
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Gho, Yong Song, 1964 (author)
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Görgens, André (author)
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Gupta, Ramesh C (author)
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Hendrix, An (author)
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Hermann, Dirk M (author)
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Hill, Andrew F (author)
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Hochberg, Fred (author)
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Horn, Peter A (author)
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de Kleijn, Dominique (author)
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Kordelas, Lambros (author)
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Kramer, Boris W (author)
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Krämer-Albers, Eva-Maria (author)
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Laner-Plamberger, Sandra (author)
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Laitinen, Saara (author)
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Leonardi, Tommaso (author)
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Lorenowicz, Magdalena J (author)
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Lim, Sai Kiang (author)
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- Lötvall, Jan, 1956 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Krefting Research Centre,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition
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Maguire, Casey A (author)
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Marcilla, Antonio (author)
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Nazarenko, Irina (author)
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Ochiya, Takahiro (author)
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Patel, Tushar (author)
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Pedersen, Shona (author)
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Pocsfalvi, Gabriella (author)
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Pluchino, Stefano (author)
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Quesenberry, Peter (author)
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Reischl, Ilona G (author)
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Rivera, Francisco J (author)
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Sanzenbacher, Ralf (author)
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Schallmoser, Katharina (author)
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Slaper-Cortenbach, Ineke (author)
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Strunk, Dirk (author)
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Tonn, Torsten (author)
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Vader, Pieter (author)
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van Balkom, Bas W M (author)
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Wauben, Marca (author)
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- Andaloussi, Samir El (author)
- Karolinska Institutet
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Théry, Clotilde (author)
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Rohde, Eva (author)
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Giebel, Bernd (author)
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(creator_code:org_t)
- 2015-12-31
- 2015
- English.
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In: Journal of extracellular vesicles. - : Wiley. - 2001-3078. ; 4
- Related links:
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https://www.tandfonl...
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https://gup.ub.gu.se...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Keyword
- haematology; immunology; neurobiology; regulation; stem cells; tissue regeneration; tumour vaccination
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Lener, Thomas
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Gimona, Mario
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Aigner, Ludwig
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Börger, Verena
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Buzas, Edit
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Camussi, Giovann ...
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show more...
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Chaput, Nathalie
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Chatterjee, Deva ...
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Court, Felipe A
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Del Portillo, He ...
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O'Driscoll, Lorr ...
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Fais, Stefano
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Falcon-Perez, Ju ...
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Felderhoff-Muese ...
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Fraile, Lorenzo
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Gho, Yong Song, ...
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Görgens, André
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Gupta, Ramesh C
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Hendrix, An
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Hermann, Dirk M
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Hill, Andrew F
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Hochberg, Fred
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Horn, Peter A
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de Kleijn, Domin ...
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Kordelas, Lambro ...
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Kramer, Boris W
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Krämer-Albers, E ...
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Laner-Plamberger ...
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Laitinen, Saara
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Leonardi, Tommas ...
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Lorenowicz, Magd ...
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Lim, Sai Kiang
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Lötvall, Jan, 19 ...
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Maguire, Casey A
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Marcilla, Antoni ...
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Nazarenko, Irina
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Ochiya, Takahiro
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Patel, Tushar
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Pedersen, Shona
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Pocsfalvi, Gabri ...
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Pluchino, Stefan ...
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Quesenberry, Pet ...
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Reischl, Ilona G
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Rivera, Francisc ...
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Sanzenbacher, Ra ...
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Schallmoser, Kat ...
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Slaper-Cortenbac ...
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Strunk, Dirk
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Tonn, Torsten
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Vader, Pieter
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van Balkom, Bas ...
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Wauben, Marca
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Andaloussi, Sami ...
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Théry, Clotilde
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Rohde, Eva
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Giebel, Bernd
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Immunology in th ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
- Articles in the publication
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Journal of extra ...
- By the university
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University of Gothenburg
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Karolinska Institutet