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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
|
| Control Group--Clinical Phase II | Active Comparator | Standard treatment for sudden deafness+dexamethasone injected into the tympanic cavity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline,7 days,1 month, and 3 months after clinical phase II treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks after intratympanic injection in the first-phase clinical |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Jiang | Contact | +86-532-82915920 | jiangyanoto@qdu.edu.cn | |
| Caili Ji | Contact | +86-532-82915920 | haidecai@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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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| Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses | Drug | 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 doses | Drug | 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 trial | Drug | 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+dexamethasone | Drug | 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. |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Guangdong General Hospital | Guangzhou | Guangdong | 519041 | China |
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| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266100 | China |
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| he Second Affiliated Hospital of Shandong First Medical University | Tai’an | Shandong | 271000 | China |
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| Chongqing General Hospital | Chongqing | Sichuan | 401121 | China |
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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