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

Qingdao University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Sudden Hearing Loss; Extracellular Vesicles

Treatments: 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: 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: Standard treatment for sudden deafness+dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07404709

QYFYEC2025-196

Details and patient eligibility

About

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

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 5 patient groups

Low-dose Treatment group-Clinical Phase I

Experimental group

Description:

Standard treatment for sudden deafness+hUC-MSC-sEV-003 at low-dose treatment in clinical phase I

Treatment:

Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses

Moderate-dose Treatment Group--Clinical Phase I

Experimental group

Description:

Standard treatment for sudden deafness+hUC-MSC-sEV-003 at moderate-dose treatment in clincal phase I

Treatment:

Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses

High-dose treatment in Clincal Phase I

Experimental group

Description:

Standard treatment for sudden deafness+hUC-MSC-sEV-003 at high-dose treatment in clincal phase I

Treatment:

Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses

Treatment Group--Clinical Phase II

Experimental group

Description:

Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by the stage I trial

Treatment:

Drug: Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trial

Control Group--Clinical Phase II

Active Comparator group

Description:

Standard treatment for sudden deafness+dexamethasone injected into the tympanic cavity

Treatment:

Drug: Standard treatment for sudden deafness+dexamethasone