Intratympanic dexamethasone‑loaded exosomes versus standard ear steroid injections for sudden sensorineural hearing loss

A Phase II, Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.

This will test whether a single intratympanic injection of dexamethasone carried by exosomes improves hearing more than standard intratympanic dexamethasone or exosome‑only injections in adults with recent sudden sensorineural hearing loss who failed oral steroids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Kafrelsheikh University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Kafr ash Shaykh, Egypt)
• Trial ID: NCT07568184 on ClinicalTrials.gov

What this trial studies

Adults with idiopathic sudden sensorineural hearing loss within 14 days who failed or cannot take systemic steroids are randomized to one of three single‑course intratympanic treatments: exosome‑loaded dexamethasone (Exo‑Dex), conventional intratympanic dexamethasone, or exosome vehicle alone. The primary endpoint is mean change in pure‑tone average (0.5, 1, 2, 4 kHz) from baseline to four weeks; secondary endpoints include safety, rates of hearing recovery at 1, 4, and 12 weeks, objective auditory testing (ABR and OAEs), and pharmacokinetic/biodistribution sub‑studies using advanced imaging. Exosomes are derived from human umbilical cord mesenchymal stem cells and are used as a local delivery vehicle to increase cochlear drug bioavailability while minimizing systemic exposure. The trial is conducted at Kafrelsheikh University in Egypt with regional collaborators.

Who should consider this trial

Good fit: Adults aged 18–65 with idiopathic SSNHL onset within 14 days who failed or have contraindications to systemic corticosteroids and can provide informed consent are the intended participants.

Not a fit: Patients with an identifiable cause of hearing loss, pre‑existing severe to profound hearing loss in the affected ear, active middle ear infection or tympanic membrane perforation, pregnancy, or known hypersensitivity to study components are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, Exo‑Dex could increase rates of hearing recovery and deliver higher inner‑ear steroid levels with fewer systemic side effects.

How similar studies have performed: Preclinical work supports exosome‑mediated drug delivery to the inner ear, but clinical use of dexamethasone‑loaded exosomes for SSNHL is novel and not yet proven in humans.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18-65 years.
2. Diagnosis of idiopathic SSNHL (≥30 dB sensorineural loss at three consecutive frequencies) within 14 days of symptom onset.
3. Failed initial standard systemic steroid therapy (e.g., oral prednisone 1 mg/kg/day for 7-14 days) or presented with contraindications to systemic steroids.
4. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Identifiable cause of hearing loss (e.g., acoustic neuroma, Meniere's disease, trauma).
2. Pre-existing severe to profound hearing loss in the affected ear.
3. Active middle ear infection or tympanic membrane perforation.
4. History of autoimmune disease, coagulation disorders, or immunodeficiency.
5. Pregnancy or lactation.
6. Known hypersensitivity to dexamethasone or components of the exosome formulation.
7. Participation in another interventional clinical trial within 30 days.

Where this trial is running

Kafr ash Shaykh, Egypt

• Kafrelsheikh University — Kafr ash Shaykh, Egypt, Egypt (Recruiting)

Study contacts

• Study coordinator: Saad Elzayat, PhD

Conditions Sensori-Neural Deafness; Exosomes; SNHL; Dexamethasone