• A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.

  NCT07568184

  RecruitingInterventionalNot ApplicableUpdated May 5, 2026
• Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

  NCT06707389

  Not yet recruitingInterventionalEarly Phase 1Updated Dec 27, 2024
• Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma

  NCT06545175

  Active, not recruitingInterventionalPhase 1Phase 2Updated Jul 16, 2026
• Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

  NCT04766853

  CompletedInterventionalPhase 1Phase 2Updated Oct 24, 2024
• Intracochlear Injection of Glucocorticoid

  NCT07134075

  Not yet recruitingInterventionalPhase 2Updated Aug 21, 2025
• Trans-round Window Membrane Intracochlear Steroid

  NCT07540728

  Not yet recruitingInterventionalPhase 2Updated Apr 20, 2026

ClinicalTrials.gov ID

NCT07404709

Lead Sponsor

The Affiliated Hospital of Qingdao UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

9Estimated

Last Update Posted

Mar 25, 2026Actual

Start Date

Feb 28, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Clinical Phase I and IIa Trials of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss

Brief Summary

The goal of this clinical trial is to learn if small extracellular vesicles derived from mesenchymal stem cells work to treat severe and above sudden sensorineural hearing loss. It will also learn about the safety of small extracellular vesicles. The main questions it aims to answer are:

1. Does small extracellular vesicles combined with traditional drug treatment improve hearing even better in severe and above sudden deafness participants?
2. What medical problems do participants have with intratympanic injection of small extracellular vesicles? Researchers will compare small extracellular vesicles to dexamethasone to see if small extracellular vesicles work to treat severe and above sudden sensorineural hearing loss.

In clinical Phase I trial, the investigators will complete the safety check and dose exploration.

Participants will:

1. Receive traditional drug treatment in accordance with the "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)

2. Receive small extracellular vesicles or a placebo tympanic injection additionally

3. Visit the clinic once every 2 weeks for checkups and tests

4. Receive tympanic injections of small extracellular vesicles ranging from low concentration to high concentration

5. Be evaluated for any adverse reactions In clinical Phase II trial, participants were randomly divided into a control group and an experimental group.

   Participants will:

6. Received intratympanic injections of small extracellular vesicles 3 times together with traditional drug treatment in experimental group

7. Received intratympanic injections of 5mg dexamethasone 3 times together with traditional drug treatment in control group, also for a total of 3 times Visit the clinic once 7 days , 1month and 3 months after treatment for checkups and tests of pure tone audiometry, speech audiometry, tinnitus disability scale and visual analogue scale assessment

• Sudden Hearing Loss
• Extracellular Vesicles

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Sudden unilateral hearing loss that occurs within 72 hours, with a decrease of at least 30 decibels in at least 3 frequency ranges compared to the healthy ear, and an average pure tone threshold of ≥ 65 decibels.
2. Enrollment must be completed within 7 days after the onset of sudden deafness.
3. Men or women aged 18 to 65
4. Not treated in any other hospital and not taking any treatment medication on one's own
5. Be able to understand the trial protocol and undergo regular follow-up visits and check-ups

Exclusion Criteria:

1. Pregnant or lactating women
2. With a history of chronic ear diseases, ear surgery, autoimmune hearing loss or a confirmed diagnosis of Meniere's syndrome in the past
3. Having received steroid treatment for any reason within the past 30 days
4. There are autoimmune diseases or chronic inflammatory diseases.
5. Severe damage to liver and kidney functions
6. Patients with a previous history of cerebral hemorrhage or those currently taking anticoagulant medications
7. Other cases in which the researchers judged the candidates to be unsuitable for inclusion

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

The Affiliated Hospital of Qingdao UniversityOTHER

xiongh@gdph.org.cn+86 13725130384