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
Key facts
- Where
- Chongqing, Guangzhou, Qingdao, and Tai’an, ChinaSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07404709, who can take part
Where in China
- Chongqing General HospitalChongqing, ChinaContact: Wei YuanNo longer taking part
- Guangdong General HospitalGuangzhou, ChinaContact: Hao XiongNo longer taking part
- the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaContact: Qingling FuNo longer taking part
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaContact: Yan JiangNo longer taking part
- he Second Affiliated Hospital of Shandong First Medical UniversityTai’an, ChinaContact: Deli WangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The Affiliated Hospital of Qingdao University
- Trial code
- NCT07404709
- Record updated
- 25 March 2026
- Original description
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:Read full original descriptionShow less
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
Inclusion: 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.
Exclusion: Having received steroid treatment for any reason within the past 30 days; Patients with a previous history of cerebral hemorrhage or those currently taking anticoagulant medications; With a history of chronic ear diseases, ear surgery, autoimmune hearing loss or a confirmed diagnosis of Meniere's syndrome in the past; There are autoimmune diseases or chronic inflammatory diseases; Pregnant or lactating women; Severe damage to liver and kidney functions; Other cases in which the researchers judged the candidates to be unsuitable for inclusion.