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Compares treatment options for Sensori-Neural Deafness
Official title A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
ClinicalTrials.gov ID: NCT07568184
What this study is testing
What is exosomes derived from human umbilical cord mesenchymal stem cells?
exosomes derived from human umbilical cord mesenchymal stem cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for sensori-neural deafness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Willing and able to provide written informed consent.
You likely can't join 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.
See the full eligibility criteria
- 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.
- 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 treatment clinical trial within 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Kafr ash Shaykh, Egypt, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kafr ash Shaykh, Egypt, Egypt. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.