sudden deafness
Conditions
Interventions
Test Group 3:For 5 consecutive days, inject 0.3ml of hucMSC sEVs into the tympanic cavity daily. 4×10^9 particle/ml
Test Group 4:For 5 consecutive days, inject 0.3ml of hucMSC sEVs into the tympanic cavity daily. 8×10^8 particle/ml
Test Group 2:For 5 consecutive days, inject 0.3ml of hucMSC sEVs into the tympanic cavity daily. 2×10^10 particle/ml
Test Group 1:For 5 consecutive days, inject 0.3ml of hucMSC sEVs into the tympanic cavity daily. 10^11 particle/ml
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily cooperated with the study and signed the informed consent form; 2. Male or female, age = 18 years; 3. Meet the diagnostic criteria for sudden onset sensorineural hearing loss within 72 hours, hearing loss at least two adjacent frequencies = 20dBHL; After receiving more than 7 days of conventional treatment with glucocorticoids, the average pure-tone hearing threshold improvement of the hearing loss frequency is less than 15 dB, and the average pure tone hearing threshold is greater than 60 dBHL before treatment; 4. Acoustic neuroma was excluded by magnetic resonance examination, and no clear cause (including systemic or local factors) was found.
Exclusion criteria
Exclusion criteria: 1. Acute or chronic infectious inflammation, tympanic membrane perforation, tympanic effusion, and middle ear cholesteatoma in the middle ear on the affected side; 2. acoustic neuroma or other central nervous system disease that causes hearing loss; 3. Other circumstances judged by the investigator to be unsuitable for inclusion; 4. exclude pregnant and lactating patients; 5. Those who are allergic to drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure-tone hearing threshold audiometry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pure-tone hearing threshold audiometry; | — |
Countries
China
Contacts
Public ContactZhang Hongzheng
Zhujiang Hospital of Southern Medical University
Outcome results
None listed