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

NCT07568184 | Recruiting DMC

• 1 other identifier: EXO-DEX-SSNHL-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective To compare the efficacy of a single course of IT Exo-Dex versus conventional IT dexamethasone and exosome vehicle alone, as measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post-treatment endpoint. Secondary Objectives

1. 1.To determine the safety and tolerability profile of IT Exo-Dex.
2. 2.To compare the rate of hearing recovery (defined as \>10 dB improvement in PTA or recovery to within 10 dB of contralateral ear) among the three treatment groups at 1, 4, and 12 weeks.
3. 3.To assess changes in auditory function via Auditory Brainstem Response (ABR) thresholds and Otoacoustic Emissions (OAEs).
4. 4.To characterize the pharmacokinetics and inner ear biodistribution of Exo-Dex using advanced imaging modalities (e.g., MRI with exosome-contrast agents in a sub-study cohort if applicable).

Conditions

Sensori-Neural Deafness; Exosomes

Keywords

Exosomes; SNHL; Dexamethasone

Outcome Measures

Primary Outcomes (2)

• To compare the efficacy of a single course of Intratympanic Exosomes-Dexamethasone versus conventional IT dexamethasone and exosome vehicle alone As measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post

  As measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post-treatment endpoint

  6 months

• Exosomes Efficacy As measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post-treatment endpoint

  within six months

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Participants treated with dexamethasone

Drug: exosomes derived from human umbilical cord mesenchymal stem cells

Intervention Group

EXPERIMENTAL

participants treated with exosomes

Drug: exosomes derived from human umbilical cord mesenchymal stem cells

Intervention Group 2

EXPERIMENTAL

participants treated with exosomes loaded with dexamethasone

Drug: exosomes derived from human umbilical cord mesenchymal stem cells

Interventions

exosomes derived from human umbilical cord mesenchymal stem cells DRUG

Exosomes (30-150 nm) are natural vesicles secreted by most cell types, playing crucial roles in intercellular communication via transport of proteins, lipids, and nucleic acids. As drug delivery vehicles, they offer intrinsic biocompatibility, low immunogenicity, and an innate ability to cross biological barriers.

Control Group; Intervention Group; Intervention Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Diagnosis of idiopathic SSNHL (≥30 dB sensorineural loss at three consecutive frequencies) within 14 days of symptom onset.
• 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.
• Willing and able to provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead
• Al-Azhar University: collaborator
• National Research Centre, Egypt: collaborator

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Egypt, 33155, Egypt

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Saad Elzayat, PhD

CONTACT

+201012788746; Samoz9@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Otorhinolaryngology, Kafrelsheikh University

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 5, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: within 1 year
• Access Criteria: Scientists in the study field

Locations

EG (1)