Evidence map›Paper›PMID 26725829›Full record

ArticleJournal of extracellular vesicles2015

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

Thomas Lener, Mario Gimona, Ludwig Aigner, Verena Börger, Edit Buzas, Giovanni Camussi, Nathalie Chaput, Devasis Chatterjee, Felipe A Court, Hernando A Del Portillo and 46 more

Open access · goldAbstract read
In one paragraph

Article in Journal of extracellular vesicles, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 945 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
945citing papers in PubMed, 3 pooled it
42.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

945 citing papers in PubMed, 3 syntheses or guidelines pooled it, 1,450 citations in OpenAlex.

  1. Pooled it
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  9. Cellular Mechanisms Enabling Mitochondria Transfer and Transplantation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
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  14. Biology and Therapeutic Potential of Exosomes, Targeted Drug Delivery.International journal of molecular sciences · 2026
    Review
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885 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

56 authors at 20 institutions in 21 countries.

Thomas LenerSpinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria.
Mario GimonaSpinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria.
Ludwig AignerSpinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria.
Verena BörgerInstitute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Edit BuzasDepartment of Genetics, Cell- and Immunobiology, Semmelweis University, Budapest, Hungary.
Giovanni CamussiMolecular Biotechnology Center, Department of Medical Sciences, University of Turin, Turin, Italy.
Nathalie ChaputLaboratory of Immunomonitoring in Oncology, UMS 3655 CNRS/US23 Inserm, Villejuif, France.
Devasis ChatterjeeDivision of Hematology & Oncology, Rhode Island Hospital, Providence, RI, USA.
Felipe A CourtDepartment of Physiology, Faculty of Biology, Pontificia-Universidad Católica de Chile, Santiago, Chile.
Hernando A Del PortilloICREA at Barcelona Centre for International Health Research (CRESIB), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.
Lorraine O'DriscollSchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland;
Stefano FaisAnti-Tumor Drugs Section, Department of Therapeutic Research and Medicines Evaluation, National Institute of Health (ISS), Rome, Italy.
Juan M Falcon-PerezMetabolomics Unit, CIC bioGUNE, CIBERehd, Bizkaia Technology Park, Derio, Spain.
Ursula Felderhoff-MueserDepartment of Paediatrics I, Neonatology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Lorenzo FraileDepartament de Producció Animal, ETSEA, Universitat de Lleida, Lleida, Spain.
Yong Song GhoDepartment of Life Sciences, Pohang University of Science and Technology, Pohang, Republic of Korea.
André GörgensInstitute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Ramesh C GuptaDepartment of Pharmacology and Toxicology, University of Louisville, Louisville, KY, USA.
An HendrixLaboratory of Experimental Cancer Research, Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium.
Dirk M HermannDepartment of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Andrew F HillDepartment of Biochemistry and Genetics, La Trobe Institute for Molecular Science, La Trobe University, Melbourne, Australia.
Fred HochbergMassachusetts General Hospital, Boston, MA, USA.
Peter A HornInstitute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Dominique de KleijnDepartment of Surgery, YLL School of Medicine, NUS, Singapore, Singapore.
Lambros KordelasDepartment of Bone Marrow Transplantation, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Boris W KramerExperimental Perinatology/Neonatology, School of Mental Health and Neuroscience, School of Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands.
Eva-Maria Krämer-AlbersMolecular Cell Biology and Focus Program Translational Neurosciences, University of Mainz, Mainz, Germany.
Sandra Laner-PlambergerSpinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria.
Saara LaitinenResearch and Cell Services, Finnish Red Cross Blood Service, Helsinki, Finland.
Tommaso LeonardiDivision of Stem Cell Neurobiology, Department of Clinical Neurosciences, Wellcome Trust-Medical Research Council Stem Cell Institute, University of Cambridge, Cambridge, UK.
Magdalena J LorenowiczDepartment of Cell Biology, Center for Molecular Medicine, University Medical Center, Utrecht, The Netherlands.
Sai Kiang LimInstitute of Medical Biology, Agency for Science Technology and Research (A*STAR), Singapore, Singapore.
Jan LötvallKrefting Research Centre, Institute of Medicine, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Casey A MaguireHarvard Medical School, Massachusetts General Hospital, Boston, MA, USA.
Antonio MarcillaDpto. Biología Celular y Parasitologia, Facultat de Farmacia, Universitat de Valencia, Valencia, Spain.
Irina NazarenkoInstitute for Environmental Health Sciences and Hospital Infection Control Medical Center, University of Freiburg, Freiburg im Breisgau, Germany.
Takahiro OchiyaDivision of Molecular and Cellular Medicine, National Cancer Center Research Institute, Tokyo, Japan.
Tushar PatelDepartments of Transplantation and Cancer Biology, Mayo Clinic, Jacksonville, FL, USA.
Shona PedersenCentre for Cardiovascular Research, Department of Clinical Biochemistry, Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
Gabriella PocsfalviMass Spectrometry and Proteomics, Institute of Biosciences and BioResources, National Research Council of Italy, Naples, Italy.
Stefano PluchinoDivision of Stem Cell Neurobiology, Department of Clinical Neurosciences, Wellcome Trust-Medical Research Council Stem Cell Institute, University of Cambridge, Cambridge, UK.
Peter QuesenberryDivision of Hematology & Oncology, Rhode Island Hospital, Providence, RI, USA.
Ilona G ReischlBASG - Bundesamt für Sicherheit im Gesundheitswesen - Federal Office for Safety in Health Care, AGES - Agentur für Gesundheit und Ernährungssicherheit - Austrian Agency for Health and Food Safety, Institut Überwachung - Institute Surveillance, Wien, Austria.
Francisco J RiveraInstitute of Molecular Regenerative Medicine, Spinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria;
Ralf SanzenbacherRalf Sanzenbacher, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Katharina SchallmoserSpinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria.
Ineke Slaper-CortenbachCell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.
Dirk StrunkExperimental & Clinical Cell Therapy Institute, Spinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University, Salzburg, Austria.
Torsten TonnInstitute for Transfusion Medicine Dresden, German Red Cross Blood Donation Service North-East, Dresden, Germany.
Pieter VaderLaboratory of Clinical Chemistry and Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.
Bas W M van BalkomDepartment of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.
Marca WaubenDepartment of Biochemistry and Cell Biology, Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.
Samir El AndaloussiDepartment of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.
Clotilde ThéryCentre of Clinical Investigation in Biotherapy CICBT 1248, Institut Gustave Roussy, Villejuif, France.
Eva RohdeSpinal Cord Injury & Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), Salzburg, Austria.
Bernd GiebelInstitute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany; bernd.giebel@uk-essen.de.
Paracelsus Medical University · ATUniversity of Duisburg-Essen · DEUtrecht University · NLProvidence College · USUniversity Medical Center Utrecht · NLAalborg University Hospital · DKAgency for Science, Technology and Research · SGAustrian Agency for Health and Food Safety · ATBarcelona Centre for International Affairs · ESCentre National de la Recherche Scientifique · FRDepartment of Medical Sciences · BYDuke-NUS Medical School · SGEssen University Hospital · DEEuropean Bioinformatics Institute · GBFinnish Red Cross · FIGerman Red Cross · DEGhent University Hospital · BEHarvard University · USIkerbasque · ESInserm · FR

Funding

Extracellular non-coding RNA biomarkers of hepatocellular cancerUH3TR000884 · NCATS · MAYO CLINIC JACKSONVILLE · PI PATEL, TUSHAR · 2015 to 2017
$3.0M
Mechanisms of Survival Signaling in Biliary EpitheliaR01DK069370 · NIDDK · SCOTT AND WHITE MEMORIAL HOSPITAL · PI PATEL, TUSHAR · 2005 to 2014
$2.4M
Regulation of renal and bone marrow injury by extracellular vesicle non-coding RNUH3TR000880 · NCATS · RHODE ISLAND HOSPITAL · PI QUESENBERRY, PETER J. · 2015 to 2017
$1.1M
NCATS NIH HHS UH3 TR000880NCATS NIH HHS UH3 TR000884NIDDK NIH HHS R01 DK069370Wellcome Trust 97922
6 · The paper itself

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.

Indexed as

haematologyimmunologyneurobiologyregulationstem cellstissue regenerationtumour vaccination

Identifiers

PMID26725829
PMCPMC4698466
OpenAlexW2207291742

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.