EXO-DEX-SNHL — Dexamethasone-Loaded Exosomes for Intratympanic Drug Delivery in Acute Sensorineural Hearing Loss
—
| Trial ID | NCT07568184 ↗ |
|---|---|
| Sponsor | Kafrelsheikh University · Egypt |
| Cell Source | 제대 중간엽줄기세포 (UC-MSC) · allogeneic |
| Indication | sensorineural-hearing-loss |
| Phase | NA |
| Status | RECRUITING |
| Delivery Route | intratympanic delivery |
| Enrollment | 30 |
| Publication | — |
Trial Design
The EXO-DEX-SNHL study is a randomised clinical trial comparing dexamethasone-loaded exosomes, conventional intratympanic dexamethasone, and exosome vehicle alone in patients with acute sensorineural hearing loss. The study is registered as a randomised, parallel-assignment, triple-masked design.
The primary objective is to compare the change in pure-tone average (PTA) at 4 weeks relative to baseline, measured at 0.5, 1, 2, and 4 kHz. Secondary objectives include safety, tolerability, hearing recovery rate at 1, 4, and 12 weeks, changes in ABR threshold, and otoacoustic emissions.
Clinical Significance
This study is notable for positioning exosomes not as a regenerative therapy in themselves, but as a drug delivery platform. Dexamethasone is an established agent in the management of sensorineural hearing loss, but inner ear delivery efficiency and duration of effect remain limited. The dexamethasone-loaded exosome approach represents an attempt to enhance drug delivery efficiency and tissue targeting.
Reasons EXO-DEX-SNHL is drawing attention:
- Exosome-based drug delivery — dexamethasone loaded into exosomes as a carrier
- Sensory organ indication — acute sensorineural hearing loss
- Active comparator — direct comparison against conventional intratympanic dexamethasone
- Objective audiological endpoints — PTA, ABR, and OAE included
Limitations and Discussion
The ClinicalTrials.gov registration does not specify a phase, which warrants caution when interpreting the developmental stage. The manufacturing method for dexamethasone-loaded exosomes, loading efficiency, drug release characteristics, and the ability to distinguish the biological effect of the exosome vehicle from the loaded drug are all critical questions. With 30 participants, any results should be interpreted as exploratory signals rather than confirmatory conclusions.