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First‐in‐human intracochlear application of human stromal cell‐derived extracellular vesicles
Author(s) -
Warnecke Athanasia,
Prenzler Nils,
Harre Jennifer,
Köhl Ulrike,
Gärtner Lutz,
Lenarz Thomas,
LanerPlamberger Sandra,
Wietzorrek Georg,
Staecker Hinrich,
Lassacher Teresa,
Hollerweger Julia,
Gimona Mario,
Rohde Eva
Publication year - 2021
Publication title -
journal of extracellular vesicles
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.94
H-Index - 68
ISSN - 2001-3078
DOI - 10.1002/jev2.12094
Subject(s) - mesenchymal stem cell , medicine , microvesicles , cochlea , stromal cell , adjuvant , extracellular vesicle , extracellular vesicles , inner ear , inflammation , clinical trial , pathology , immunology , microbiology and biotechnology , biology , audiology , anatomy , microrna , biochemistry , gene
Extracellular vesicles (EVs) derived from the secretome of human mesenchymal stromal cells (MSC) contain numerous factors that are known to exert anti‐inflammatory effects. MSC‐EVs may serve as promising cell‐based therapeutics for the inner ear to attenuate inflammation‐based side effects from cochlear implantation which represents an unmet clinical need. In an individual treatment performed on a ‘named patient basis’, we intraoperatively applied allogeneic umbilical cord‐derived MSC‐EVs (UC‐MSC‐EVs) produced according to good manufacturing practice. A 55‐year‐old patient suffering from Menière's disease was treated with intracochlear delivery of EVs prior to the insertion of a cochlear implant. This first‐in‐human use of UC‐MSC‐EVs demonstrates the feasibility of this novel adjuvant therapeutic approach. The safety and efficacy of intracochlear EV‐application to attenuate side effects of cochlea implants have to be determined in controlled clinical trials.

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