Evidence map›Paper›PMID 34136108›Full record

ArticleJournal of extracellular vesicles2021

First-in-human intracochlear application of human stromal cell-derived extracellular vesicles.

Athanasia Warnecke, Nils Prenzler, Jennifer Harre, Ulrike Köhl, Lutz Gärtner, Thomas Lenarz, Sandra Laner-Plamberger, Georg Wietzorrek, Hinrich Staecker, Teresa Lassacher and 3 more

Abstract readLetter
In one paragraph

Article in Journal of extracellular vesicles, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

58 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Clinical Applications of Extracellular Vesicles: Promises and Pitfalls.International journal of molecular sciences · 2026
    Review
  9. Review
  10. Review
  11. Extracellular vesicles in preeclampsia: drivers of vascular dysfunction and inflammation.American journal of physiology. Heart and circulatory physiology · 2025
    Review
  12. Article
  13. Round window membrane extracellular vesicles facilitate inner ear drug delivery.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
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

13 authors.

Athanasia WarneckeDepartment of Otorhinolaryngology, Head and Neck Surgery Hannover Medical School Hannover Germany.
Nils PrenzlerDepartment of Otorhinolaryngology, Head and Neck Surgery Hannover Medical School Hannover Germany.
Jennifer HarreDepartment of Otorhinolaryngology, Head and Neck Surgery Hannover Medical School Hannover Germany.
Ulrike KöhlInstitute 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.
Lutz GärtnerDepartment of Otorhinolaryngology, Head and Neck Surgery Hannover Medical School Hannover Germany.
Thomas LenarzDepartment of Otorhinolaryngology, Head and Neck Surgery Hannover Medical School Hannover Germany.
Sandra Laner-PlambergerDepartment of Transfusion Medicine University Hospital Salzburger Landeskliniken GesmbH (SALK) and Paracelsus Medical University (PMU) Salzburg Austria.
Georg WietzorrekInstitute of Molecular and Cellular Pharmacology Medical University of Innsbruck Innsbruck Austria.
Hinrich StaeckerDepartment of Otolaryngology Head and Neck Surgery University of Kansas School of Medicine Kansas City Kansas USA.
Teresa LassacherGMP Unit Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University (PMU) Salzburg Austria.
Julia HollerwegerGMP Unit Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University (PMU) Salzburg Austria.
Mario GimonaDepartment of Transfusion Medicine University Hospital Salzburger Landeskliniken GesmbH (SALK) and Paracelsus Medical University (PMU) Salzburg Austria.
Eva RohdeDepartment of Transfusion Medicine University Hospital Salzburger Landeskliniken GesmbH (SALK) and Paracelsus Medical University (PMU) Salzburg Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Cell DifferentiationCochlear ImplantationCochlear ImplantsCytokinesEar, InnerExtracellular VesiclesHumansMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedPilot ProjectsUmbilical CordCytokinescochlear implantationEVs from umbilical cord‐derived mesenchymal stromal cells (UC‐MSC‐EV)extracellular vesiclesfirst‐in‐human intracochlear EV‐therapyhearing lossimmunomodulationMenière's diseasevesicle‐enriched secretome fraction

Identifiers

PMID34136108
PMCPMC8178433

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.