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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-05

No results posted yet for this study

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. To determine the safety and tolerability profile of IT Exo-Dex.
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. To assess changes in auditory function via Auditory Brainstem Response (ABR) thresholds and Otoacoustic Emissions (OAEs).
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

Interventions

DRUG

exosomes derived from human umbilical cord mesenchymal stem cells

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.

Sponsors & Collaborators

  • Al-Azhar University

    collaborator OTHER

  • National Research Centre, Egypt

    collaborator OTHER

  • Kafrelsheikh University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-03
Primary Completion
2027-04-30
Completion
2027-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07568184 on ClinicalTrials.gov