Sudden Hearing LossPhase 1/2NCT07404709
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
A Phase 1/2 study testing 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 and Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses in people with Sudden Hearing Loss and Extracellular Vesicles, run by The Affiliated Hospital of Qingdao University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sudden Hearing Loss, Extracellular Vesicles
- What is being tested?
- 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 and Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesChina
- Study dates
- 28 Feb 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Chongqing General Hospital
Chongqing, Sichuan, 401121
Wei Yuan, +8613368228269, yuanwei@ucas.ac.cn
Wei Yuan
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Qingling Fu, +8613699726862, fuqingl@mail.sysu.edu.cn
Qingling Fu
Guangdong General Hospital
Guangzhou, Guangdong, 519041
Hao Xiong, +86 13725130384, xiongh@gdph.org.cn
Hao Xiong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266100
Yan Jiang, +86-532-82915920, jiangyanoto@qdu.edu.cn
Caili Ji, haidecai@163.com
he Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
Deli Wang, +8615621335297, WDLWNY@163.com
Deli Wang
About this study
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
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:
- Does small extracellular vesicles combined with traditional drug treatment improve hearing even better in severe and above sudden deafness participants?
- 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.
Read more
In clinical Phase I trial, the investigators will complete the safety check and dose exploration.
Participants will:
- Receive traditional drug treatment in accordance with the "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)
- Receive small extracellular vesicles or a placebo tympanic injection additionally
- Visit the clinic once every 2 weeks for checkups and tests
- Receive tympanic injections of small extracellular vesicles ranging from low concentration to high concentration
- 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:
- Received intratympanic injections of small extracellular vesicles 3 times together with traditional drug treatment in experimental group
- 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
- Conditions
- Sudden Hearing Loss, Extracellular Vesicles
- Being tested
- 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
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low dosesDrug
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.
Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate dosesDrug
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.
Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high dosesDrug
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.
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trialDrug
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.
Standard treatment for sudden deafness+dexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Treatment group-Clinical Phase I | Experimental | Standard treatment for sudden deafness+hUC-MSC-sEV-003 at low-dose treatment in clinical phase I Receives: Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses |
| Moderate-dose Treatment Group--Clinical Phase I | Experimental | Standard treatment for sudden deafness+hUC-MSC-sEV-003 at moderate-dose treatment in clincal phase I Receives: Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses |
| High-dose treatment in Clincal Phase I | Experimental | Standard treatment for sudden deafness+hUC-MSC-sEV-003 at high-dose treatment in clincal phase I Receives: Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses |
| Treatment Group--Clinical Phase II | Experimental | Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by the stage I trial Receives: 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 | Standard treatment for sudden deafness+dexamethasone injected into the tympanic cavity Receives: Drug: Standard treatment for sudden deafness+dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone test
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.
Measured: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
speech audiometry
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.
Measured: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
Secondary outcomes (9)
Respiration
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.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Heart rate
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.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Oxygen saturation
The investigators also monitor vital signs oxygen saturation. The unit of oxygen saturation is percent with the normal range of 95% to 100%.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Blood pressure
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.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
tympanic membrane healing status
The investigators observe the healing status of the eardrum. There are two possible outcomes: the eardrum heals or it does not heal.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Haematological index on liver function
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.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Haematological index on kidney function
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.
Measured: Baseline, 2 weeks after intratympanic injection in the first-phase clinical
Tinnitus Handicap Inventory
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.
Measured: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
Visual Analogue Scale
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.
Measured: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Hearing LossStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jiangyan, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404709
- Sponsor's protocol ID
- QYFYEC2025-196
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07404709
- Acronym / sponsor ID
- QYFYEC2025-196
- Conditions
- Sudden Hearing Loss, Extracellular Vesicles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does small extracellular vesicles combined with traditional drug treatment improve hearing even better in severe and above sudden deafness participants?
- 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:
- Receive traditional drug treatment in accordance with the "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)
- Receive small extracellular vesicles or a placebo tympanic injection additionally
- Visit the clinic once every 2 weeks for checkups and tests
- Receive tympanic injections of small extracellular vesicles ranging from low concentration to high concentration
- 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:
- Received intratympanic injections of small extracellular vesicles 3 times together with traditional drug treatment in experimental group
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-dose Treatment group-Clinical Phase I | Experimental | Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low dosesStandard treatment for sudden deafness+hUC-MSC-sEV-003 at low-dose treatment in clinical phase I |
| Moderate-dose Treatment Group--Clinical Phase I | Experimental | Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate dosesStandard treatment for sudden deafness+hUC-MSC-sEV-003 at moderate-dose treatment in clincal phase I |
| High-dose treatment in Clincal Phase I | Experimental | Drug: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high dosesStandard treatment for sudden deafness+hUC-MSC-sEV-003 at high-dose treatment in clincal phase I |
| Treatment Group--Clinical Phase II | Experimental | Drug: Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trialStandard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by the stage I trial |
| Control Group--Clinical Phase II | Active comparator | Drug: Standard treatment for sudden deafness+dexamethasoneStandard treatment for sudden deafness+dexamethasone injected into the tympanic cavity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low dosesIn 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. | Drug | Low-dose Treatment group-Clinical Phase I |
| Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate dosesIn 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. | Drug | Moderate-dose Treatment Group--Clinical Phase I |
| Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high dosesn 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. | Drug | High-dose treatment in Clincal Phase I |
| Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trialAfter 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. | Drug | Treatment Group--Clinical Phase II |
| Standard treatment for sudden deafness+dexamethasoneParticipants 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. | Drug | Control Group--Clinical Phase II |
Primary outcome
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.
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.
9 secondary outcomes
Respiration
Time frame: 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
Oxygen saturation
Time frame: 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
tympanic membrane healing status
Time frame: 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
Haematological index on kidney function
Time frame: 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
Visual Analogue Scale
Time frame: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 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 and Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses in people with Sudden Hearing Loss and Extracellular Vesicles, run by The Affiliated Hospital of Qingdao University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Jiang (+86-532-82915920, jiangyanoto@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone test (time frame: Baseline,7 days,1 month, and 3 months after clinical phase II treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.