# Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss

> **NCT07404709** · PHASE1,PHASE2 · NOT_YET_RECRUITING · sponsor: **The Affiliated Hospital of Qingdao University** · enrollment: 9 (estimated)

## Conditions studied

- Sudden Hearing Loss
- Extracellular Vesicles

## Interventions

- **DRUG:** Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses
- **DRUG:** Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses
- **DRUG:** Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses
- **DRUG:** Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trial
- **DRUG:** Standard treatment for sudden deafness+dexamethasone

## Key facts

- **NCT ID:** NCT07404709
- **Lead sponsor:** The Affiliated Hospital of Qingdao University
- **Sponsor class:** OTHER
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-02-28
- **Primary completion:** 2027-12-31
- **Final completion:** 2028-12-31
- **Target enrollment:** 9 (ESTIMATED)
- **Last updated:** 2026-03-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07404709

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07404709, "Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT07404709. Licensed CC0.

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