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

Starting soon · Phase 1/Phase 2

Conditions studied: Sudden Hearing Loss, Extracellular Vesicles

In brief

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

Key facts

Study ID: NCT07404709
Run by: The Affiliated Hospital of Qingdao University
People needed: 9
Starts: 2026-02-28
Expected to finish: 2028-12-31
Last updated by the study team: 2026-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Enrollment must be completed within 7 days after the onset of sudden deafness.
Men or women aged 18 to 65
Not treated in any other hospital and not taking any treatment medication on one's own
Be able to understand the trial protocol and undergo regular follow-up visits and check-ups

You may not qualify if…

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

Where it is running

The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
Guangdong General Hospital — Guangzhou, Guangdong, China
The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
he Second Affiliated Hospital of Shandong First Medical University — Tai’an, Shandong, China
Chongqing General Hospital — Chongqing, Sichuan, China

Full record on ClinicalTrials.gov

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