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

March 21, 2026 updated by: jiangyan, The Affiliated Hospital of Qingdao University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Qingling Fu
      • Guangzhou, Guangdong, China, 519041
        • Guangdong General Hospital
        • Principal Investigator:
          • Hao Xiong
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266100
        • The Affiliated Hospital of Qingdao University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yan Jiang, MD
      • Tai’an, Shandong, China, 271000
        • he Second Affiliated Hospital of Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Deli Wang
    • Sichuan
      • Chongqing, Sichuan, China, 401121
        • Chongqing General Hospital
        • Principal Investigator:
          • Wei Yuan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group--Clinical Phase II
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by the stage I trial
Drug: Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trial
After the safety verification and dose determination of the Phase I clinical trial were completed, about 20 participants received standard treatment in accordance with the "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)", and at the same time, they were administered intratympanic injections of small extracellular vesicles every other day, for a total of 3 times.
Experimental: Low-dose Treatment group-Clinical Phase I
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at low-dose treatment in clinical phase I
Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses
In Clinical Phase I, three participants were first injected with small extracellular vesicles at low doses (2×108particles/mL) together with traditional drug treatment. The intratympanic injection of small extracellular vesicles was given every other day for a total of 3 times for every participants.
Experimental: Moderate-dose Treatment Group--Clinical Phase I
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at moderate-dose treatment in clincal phase I
Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses
In Clinical Phase I, if no adverse reactions were observed for 2 weeks after the low-dose group was injected, three participants were then injected with small extracellular vesicles at moderat doses (1×109particles/mL) together with traditional drug treatment. The intratympanic injection of small extracellular vesicles was given every other day for a total of 3 times for every participants.
Experimental: High-dose treatment in Clincal Phase I
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at high-dose treatment in clincal phase I
Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses
n Clinical Phase I, if no adverse reactions were observed for 2 weeks after the moderate-dose group was injected, three participants were then injected with small extracellular vesicles at high doses (5×109particles/mL) together with traditional drug treatment. The intratympanic injection of small extracellular vesicles was given every other day for a total of 3 times for every participants.
Active Comparator: Control Group--Clinical Phase II
Standard treatment for sudden deafness+dexamethasone injected into the tympanic cavity
Drug: Standard treatment for sudden deafness+dexamethasone
Participants in the control group received standard treatment in accordance with the "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)", and during their hospitalization, they received intratympanic injections of dexamethasone at a dose of 5mg every other day for a total of 3 times.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pure tone test
Time Frame: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
The hearing recovery status is evaluated based on the changes in pure tone threshold from the baseline at enrollment to 3 months of follow-up. The pure tone threshold is the average of air conduction thresholds at 0.25, 0.5, 1, 2, 4 kHz, and 8 kHz.
Baseline,7 days,1 month, and 3 months after clinical phase II treatment
speech audiometry
Time Frame: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
The hearing recovery status is also evaluated based on the changes in speech recognition rate from the baseline at enrollment to 3 months of follow-up. The speech audiometry results use the speech recognition rates at the baseline and after treatment of the subjects.
Baseline,7 days,1 month, and 3 months after clinical phase II treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiration
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators monitor vital signs respiration. The unit of respiratory rate is breaths per minute with the normal range 12 to 20 beats per minute.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Heart rate
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators also monitor vital signs heart rate. The unit of heart rate is beats per minute with the normal range 60 to 100 beats per minute at rest.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Oxygen saturation
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators also monitor vital signs oxygen saturation. The unit of oxygen saturation is percent with the normal range of 95% to 100%.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Blood pressure
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators also monitor vital signs blood pressure. The unit of blood pressure is mmHg. The normal range is that the systolic pressure should not exceed 140 mmHg, the diastolic pressure should not exceed 90 mmHg, and the blood pressure level should be no less than 90/60 mmHg.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
tympanic membrane healing status
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators observe the healing status of the eardrum. There are two possible outcomes: the eardrum heals or it does not heal.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Haematological index on liver function
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators assess the changes in haematological index on liver function and kidney function levels compared to the baseline. The indicators for evaluating liver function include biochemical indicators such as albumin, transaminases, and bilirubin.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Haematological index on kidney function
Time Frame: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
The investigators assess the changes in haematological index on kidney function levels compared to the baseline. The indicators for evaluating kidney function include biochemical parameters such as serum creatinine, urea nitrogen, uric acid, glomerular filtration rate, and urine protein.
Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Tinnitus Handicap Inventory
Time Frame: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
The assessment of the tinnitus symptoms of the participants is conducted using the Tinnitus Handicap Inventory at both the baseline and different post-treatment periods. This scale classifies tinnitus into four grades as follows: Grade 1 (mild), corresponding to a Tinnitus Handicap Inventory score of 1 to 16. The tinnitus sound is faint and sometimes present, sometimes absent. Grade 2 (moderate), with a Tinnitus Handicap Inventory score of 18 to 36. The tinnitus sound is relatively obvious but generally has a minor impact. Grade 3 (moderately severe), with a Tinnitus Handicap Inventory score of 38 to 56. The tinnitus sound is moderate and begins to cause some interference in daily life. Grade 4 (severe), with a Tinnitus Handicap Inventory score of 58 to 76. A higher score means a worse result.
Baseline,7 days,1 month, and 3 months after clinical phase II treatment
Visual Analogue Scale
Time Frame: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
The psychological assessment of the participants is carried out using the Visual Analogue Scale.The VAS scoring standard uses a straight line or ruler approximately 10 centimeters long, with the two ends marked as 0 and 10 respectively. 0 indicates no pain, and 10 indicates severe pain. Participants mark the corresponding position according to the degree of pain. 2. Pain grading: 0 indicates no pain; 1-3 indicates mild pain; 4-6 indicates moderate pain; 7-9 indicates severe pain; 10 indicates extreme pain. In this scale，a higher score means a worse result.
Baseline,7 days,1 month, and 3 months after clinical phase II treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QYFYEC2025-196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The informed consent form of this study does not include clauses authorizing IPD sharing. As a Phase I/II exploratory study, the data involves sensitive medical information and preliminary research results. To protect participants' privacy and comply with ethical and regulatory requirements, the data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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