Sudden DeafnessEarly Phase 1NCT06707389
Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness
A Early Phase 1 study testing autologous blood monocyte vesicles (lower dose), Methylprednisolone and autologous blood monocyte vesicles (higher dose) in people with Sudden Deafness and Sensorineural Hearing Loss, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Sudden deafness is a common emergency in otorhinolaryngology. As the etiology and mechanism of sudden deafness remains unknown, there is no specific treatment. Therefore, to explore new treatments for sudden deafness is a urgent and challenging problem. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sudden Deafness, Sensorineural Hearing Loss
- What is being tested?
- autologous blood monocyte vesicles (lower dose), Methylprednisolone and autologous blood monocyte vesicles (higher dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2024to 1 Jun 2027
- Phase
- Early Phase 1
- 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
- Patients aged between 18 and 65.
- Patients with severe and above unilateral hearing loss who meet the diagnostic criteria for sudden deafness.
- Patients who suffer sudden deafness within 3 weeks and do not receive intratympanic injection.
- Patients who fully understand the purpose and requirements of the trial, volunteer to participate in the clinical trial, sign a written informed consent, and is willing to complete the whole trial process according to the trial requirements.
Who cannot join
- Patients with conductive deafness and mixed deafness;
- Patients with other otologic diseases;
- Those who have doubts about the treatment plan or have obvious mental and psychological disorders;
- Patients with severe heart, lung, liver and kidney dysfunction;
- Patients with severe hematological diseases or tumors (especially those with acoustic neuromas);
- Those with positive HIV antibody, HBsAg, HCV antibody, or serological examination results for syphilis;
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- Patients with a history of infection within 1 month prior to screening, requiring hospitalization and / or antibiotics, or currently using systemic hormones (corticosteroids), immunosuppressants or cytotoxicity;
- Patients with a history of immune system diseases or hematological system diseases;
- Patients with abnormal blood findings, such as abnormal number and morphology of red blood cells, white blood cells and platelets;
- Patients with severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine, and central nervous system diseases;
- Women during lactation, pregnancy, or possibly pregnancy;
- Patients with contraindications or allergies to the treatment of this study;
- Those who have participated in any clinical drug trial in the past 3 months;
- Patients that the Investigator considers unsuitable to participate in the trial;
- Patients not suitable for tympanic injection therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Huang Xiaotong contact
About this study
Official title: A Pilot Study of Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness
Sudden deafness is a common emergency in otorhinolaryngology. As the etiology and mechanism of sudden deafness remains unknown, there is no specific treatment. Therefore, to explore new treatments for sudden deafness is a urgent and challenging problem. Extracellular vesicles therapy has been proved to be effective for several diseases. From our previous study, extracellular vesicles from mesenchymal stem cell can effectively improve noise-induced sensorineural deafness in mice. While mesenchymal stem cell therapy faces immune rejection in clinical use, the investigators use autologous blood monocyte vesicles to avoid immune rejection and guarantee patients' safety. In this interventional study, the investigators aimed to study the clinical effects and adverse reactions of autologous blood monocyte vesicle therapy in the treatment of sudden deafness. A total of 30 patients with severe or worse sudden deafness will enroll in this study and randomly assigned to 3 group, which are control group (Intratympanic glucocorticoid injection), lower-dose apoVs group (lower dose of Intratympanic monocyte vesicles injection) and higher-dose apoVs group (higher dose of Intratympanic monocyte vesicles injection). This study will further promote new treatment for sudden deafness and improve the quality of life and prognosis of patients with sudden deafness, especially those with severe or extremely severe deafness.
- Conditions
- Sudden Deafness, Sensorineural Hearing Loss
- Being tested
- autologous blood monocyte vesicles (lower dose), Methylprednisolone, autologous blood monocyte vesicles (higher dose)
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous blood monocyte vesicles (lower dose)Biological
20 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week.
40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Intratympanic injection of methylprednisolone was performed three times a week.
autologous blood monocyte vesicles (higher dose)Biological
50 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Intratympanic injection of methylprednisolone (methylprednisolone succinic acid for injection) at a dose of 40mg/mL, three times a week. 40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Receives: Drug: Methylprednisolone |
| apoVs(lower dose) | Experimental | Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 20 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Receives: Biological: autologous blood monocyte vesicles (lower dose) |
| apoVs(higher dose) | Experimental | Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 50 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Receives: Biological: autologous blood monocyte vesicles (higher dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry
Pure tone audiometry.
Measured: 4 weeks after intervention.
Secondary outcomes (5)
Audiometry
Pure tone audiometry
Measured: 1 week, 2 weeks after intervention
THI scale
THI (tinnitus handicap inventory) is one of the most widely used tinnitus self-rating scales in the world.It consists of three dimensions: functional, emotional and severity and effect of decreased tinnitus on patients\' daily life. The THI score is totally 100 points. The more score participants get, the severer tinnitus symtoms they suffer from. According to the total score, paticipants were divided into five grades, Grade I (0-16, light) , Grade II (18-36, mild) , Grade III (38-56, moderate) , grade IV (58-76, severe) , grade V (78-100, catastrophic).
Measured: 1 week, 2 weeks, 4 weeks after intervention.
Tinnitus VAS
The VAS(visual analogue scale) for subjective severity of tinnitus focuses on the subjective assessment of general sensation. The VAS has a scale score of 0 to 10, with 0 being completely unaffected and 10 being very severely affected.
Measured: 1 week, 2 weeks, 4 weeks after intervention.
SAS
The SAS(Self-Rating Anxiety Scale) consists of 20 items which reflect the subjective and feeling of Anxiety. The more score paticipants get, the more anxiety they suffer. The SAS score can be divided into 4 levels: normal(less than 50 score), mild anxiety(50-59 score), moderate anxiety(60-69 score) and severe anxiety(more than 69 score).
Measured: 1 week, 2 weeks, 4 weeks after intervention.
Adverse Events
Local adverse events include hearing loss, otitis media, and unperforation of tympanic membrane. Systemic adverse events include vital signs instability, new-onset anemia, liver and kidney dysfunction and so on. The severity of adverse events was graded according to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0, Grade 1: mild; asymptomatic or mild; clinical or diagnostic only; treatment free. Grade 2: Moderate; requiring small, local, or non-invasive treatment; limited instrumental daily living activities comparable to age. Grade 3: serious or medically significant but not immediately life threatening; hospitalization or prolonged hospitalization; disability; limited activities of daily life. Grade 4: life-threatening; requiring urgent treatment. Grade 5: Death related to AEs.
Measured: 1 week, 2 weeks, 4 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start25 Dec 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden DeafnessStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707389
- Sponsor's protocol ID
- SYSKY-2023-1250-02
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness
- ClinicalTrials.gov ID
- NCT06707389
- Acronym / sponsor ID
- SYSKY-2023-1250-02
- Conditions
- Sudden Deafness, Sensorineural Hearing Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Nov 2024 (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.
Sudden deafness is a common emergency in otorhinolaryngology. As the etiology and mechanism of sudden deafness remains unknown, there is no specific treatment. Therefore, to explore new treatments for sudden deafness is a urgent and challenging problem. Extracellular vesicles therapy has been proved to be effective for several diseases. From our previous study, extracellular vesicles from mesenchymal stem cell can effectively improve noise-induced sensorineural deafness in mice. While mesenchymal stem cell therapy faces immune rejection in clinical use, the investigators use autologous blood monocyte vesicles to avoid immune rejection and guarantee patients' safety. In this interventional study, the investigators aimed to study the clinical effects and adverse reactions of autologous blood monocyte vesicle therapy in the treatment of sudden deafness. A total of 30 patients with severe or worse sudden deafness will enroll in this study and randomly assigned to 3 group, which are control group (Intratympanic glucocorticoid injection), lower-dose apoVs group (lower dose of Intratympanic monocyte vesicles injection) and higher-dose apoVs group (higher dose of Intratympanic monocyte vesicles injection). This study will further promote new treatment for sudden deafness and improve the quality of life and prognosis of patients with sudden deafness, especially those with severe or extremely severe deafness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: MethylprednisoloneIntratympanic injection of methylprednisolone (methylprednisolone succinic acid for injection) at a dose of 40mg/mL, three times a week. 40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. |
| apoVs(lower dose) | Experimental | Biological: autologous blood monocyte vesicles (lower dose)Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 20 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. |
| apoVs(higher dose) | Experimental | Biological: autologous blood monocyte vesicles (higher dose)Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 50 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 65.
- Patients with severe and above unilateral hearing loss who meet the diagnostic criteria for sudden deafness.
- Patients who suffer sudden deafness within 3 weeks and do not receive intratympanic injection.
- Patients who fully understand the purpose and requirements of the trial, volunteer to participate in the clinical trial, sign a written informed consent, and is willing to complete the whole trial process according to the trial requirements.
Key exclusion criteria (15 listed)
- Patients with conductive deafness and mixed deafness;
- Patients with other otologic diseases;
- Those who have doubts about the treatment plan or have obvious mental and psychological disorders;
- Patients with severe heart, lung, liver and kidney dysfunction;
- Patients with severe hematological diseases or tumors (especially those with acoustic neuromas);
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 |
|---|---|---|
| autologous blood monocyte vesicles (lower dose)20 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week. | Biological | apoVs(lower dose) |
| Methylprednisolone40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Intratympanic injection of methylprednisolone was performed three times a week. | Drug | control |
| autologous blood monocyte vesicles (higher dose)50 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week. | Biological | apoVs(higher dose) |
Primary outcome
Audiometry
Time frame: 4 weeks after intervention.
Pure tone audiometry.
5 secondary outcomes
Audiometry
Time frame: 1 week, 2 weeks after intervention
THI scale
Time frame: 1 week, 2 weeks, 4 weeks after intervention.
Tinnitus VAS
Time frame: 1 week, 2 weeks, 4 weeks after intervention.
SAS
Time frame: 1 week, 2 weeks, 4 weeks after intervention.
Adverse Events
Time frame: 1 week, 2 weeks, 4 weeks after intervention.
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 27 Dec 2024.
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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.
Huang Xiaotong contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing autologous blood monocyte vesicles (lower dose), Methylprednisolone and autologous blood monocyte vesicles (higher dose) in people with Sudden Deafness and Sensorineural Hearing Loss, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 4 inclusion and 15 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yang Haidi, Doctor (13178821663, yanghd@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiometry (time frame: 4 weeks after intervention.). 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 27 Dec 2024.