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A Randomized Controlled Trial on the Efficacy of Tympanic Membrane Injection of PTMSC Exosomes in the Treatment of Sudden Deafness

A Randomized Controlled Trial on the Efficacy of Tympanic Membrane Injection of PTMSC Exosomes in the Treatment of Sudden Deafness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115760
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural hearing loss

Interventions

Experimental group:Combined use of PTMSC exosome tympanic cavity injection with dexamethasone injection solution
Control group:Tympanic cavity injection of dexamethasone injection

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) The subjects voluntarily cooperated with the study and signed the informed consent. (2) Male or female, aged >=18 years; (3) Sudden sensorineural hearing loss with unexplained hearing loss of more than 30 dB for three consecutive frequencies within 72 hours; (4) With or without other treatment, the average pure tone hearing threshold of hearing loss frequency improved less than 15dB, and the average pure tone hearing threshold before treatment was more than 35dBHL; (5) The onset time was <=28 days, and the treatment with conventional corticosteroids (oral or intravenous injection) for more than 3 days was ineffective; Or onset time <=28 days and contraindications to systemic use of glucocorticoids. (6) Acoustic neuroma was excluded by magnetic resonance imaging (MRI), and no definite etiology (including systemic or local factors) was found.

Exclusion criteria

Exclusion criteria: (1) Acute or chronic infectious inflammation of the middle ear on the affected side, tympanic membrane perforation, tympanic effusion, or cholesteatoma of the middle ear; (2) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period; (3)Other circumstances deemed ineligible for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Pure-tone audiometry;

Countries

China

Contacts

Public ContactZhang Hongzheng

Zhujiang Hospital of Southern Medical University

zhanghongzheng@vip.163.com+86 20 61643064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026