6533b872fe1ef96bd12d3079
RESEARCH PRODUCT
Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper.
Thomas LenerMario GimonaLudwig AignerVerena BörgerEdit BuzasGiovanni CamussiNathalie ChaputDevasis ChatterjeeFelipe A. CourtHernando A Del PortilloLorraine O'driscollStefano FaisJuan M Falcon-perezUrsula Felderhoff-mueserLorenzo FraileYong Song GhoAndré GörgensRamesh C GuptaAn HendrixDirk M HermannAndrew F. HillFred HochbergPeter A HornDominique De KleijnLambros KordelasBoris W KramerEva-maria Krämer-albersSandra Laner-plambergerSaara LaitinenTommaso LeonardiMagdalena J LorenowiczSai Kiang LimJan LötvallCasey A MaguireAntonio MarcillaIrina NazarenkoTakahiro OchiyaTushar PatelShona PedersenGabriella PocsfalviStefano PluchinoPeter QuesenberryIlona G ReischlFrancisco J RiveraRalf SanzenbacherKatharina SchallmoserIneke Slaper-cortenbachDirk StrunkTorsten TonnPieter VaderBas W M Van BalkomMarca WaubenSamir El AndaloussiClotilde ThéryEva RohdeBernd GiebelInfection & ImmunityFertility & ReproductionDi&i I&i-1Db&c I&iLs Celbiologie-algemeensubject
Bioquímica clínicaMedizinISCHEMIA-REPERFUSION INJURYBioinformaticsimmunology; neurobiology; haematology; stem cells; tissue regeneration; tumour vaccination; regulationimmunology0302 clinical medicineClinical trialsClinical investigationVERSUS-HOST-DISEASEMedicine and Health SciencesFIELD-FLOW FRACTIONATIONMedicineImmunologiahaematology; immunology; neurobiology; regulation; stem cells; tissue regeneration; tumour vaccinationmedia_common0303 health scienceslcsh:CytologyOUTER-MEMBRANE VESICLESneurobiologyregulationHematologyBiologia experimental3. Good healthTUMOR-DERIVED EXOSOMES030220 oncology & carcinogenesistumour vaccinationDrug deliveryhaematologyPosition PaperCèl·lules mareNeurobiologiaHistologyMedicina InvestigacióCèl·lulesNANOPARTICLE TRACKING ANALYSIStissue regenerationExtracellular vesiclesMESENCHYMAL STEM-CELLS03 medical and health sciencesstem cellsJournal Articlemedia_common.cataloged_instanceREGULATORY T-CELLSEuropean unionlcsh:QH573-671ENDOTHELIAL PROGENITOR CELLSHematologia030304 developmental biologybusiness.industryCell BiologyMicrovesiclesClinical trialPosition paperPharmaceutical manufacturingUMBILICAL-CORD BLOODbusinessNeuroscienceAssaigs clínicsdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2015-12-01 |