First‐in‐human intracochlear application of human stromal cell‐derived extracellular vesicles

Journal of Extracellular Vesicles

Hinrich Staecker¹  Thomas Lenarz²  Athanasia Warnecke²  Nils Prenzler²  Jennifer Harre²  Lutz Gärtner²  Sandra Laner‐Plamberger³  Eva Rohde³  Mario Gimona³  Julia Hollerweger⁴  Teresa Lassacher⁴  Ulrike Köhl⁵  Georg Wietzorrek⁶ 

[1] Department of Otolaryngology Head and Neck Surgery University of Kansas School of Medicine Kansas City Kansas USA;Department of Otorhinolaryngology, Head and Neck Surgery Hannover Medical School Hannover Germany;Department of Transfusion Medicine University Hospital Salzburger Landeskliniken GesmbH (SALK) and Paracelsus Medical University (PMU) Salzburg Austria;GMP Unit Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI‐TReCS) Paracelsus Medical University (PMU) Salzburg Austria;Institute for Cellular Therapeutics Hannover and Institute of Clinical Immunology Hannover Medical School University of Leipzig as well as Fraunhofer Institute for Cell Therapy and Immunology (IZI) Leipzig Germany;Institute of Molecular and Cellular Pharmacology Medical University of Innsbruck Innsbruck Austria;

关键词: cochlear implantation;    EVs from umbilical cord‐derived mesenchymal stromal cells (UC‐MSC‐EV);    extracellular vesicles;    first‐in‐human intracochlear EV‐therapy;    hearing loss;    immunomodulation;   

DOI  :  10.1002/jev2.12094

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown