Sensori-Neural DeafnessEXO-DEX-SNHLNCT07568184
A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.
A study testing exosomes derived from human umbilical cord mesenchymal stem cells in people with Sensori-Neural Deafness and Exosomes, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sensori-Neural Deafness, Exosomes
- What is being tested?
- exosomes derived from human umbilical cord mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Egypt, 33155
Haitham Hassan Elfarargy, 002 0473109590, Hitham_Elfarargy@med.kfs.edu.eg
Hussein El-Shirbeny, 002 01012788746, hassien.med_0127@med.kfs.edu.eg
About this study
Official title: 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.
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
- To determine the safety and tolerability profile of IT Exo-Dex.
- 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.
- To assess changes in auditory function via Auditory Brainstem Response (ABR) thresholds and Otoacoustic Emissions (OAEs).
- 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).
Read the detailed description
SSNHL is defined as a rapid-onset hearing loss of ≥30 dB over at least three contiguous frequencies within a 72-hour period, with an incidence of 5-20 per 100,000 persons annually (1).
The idiopathic nature of most cases suggests multifactorial pathogenesis, including viral infections, autoimmune responses, and vascular ischemia, culminating in cochlear inflammation and oxidative stress (2).
The standard of care involves systemic corticosteroids, with salvage IT corticosteroid injections for non-responders. However, the blood-labyrinth barrier and the round window membrane pose significant anatomical and physiological barriers to effective drug delivery, resulting in sub-therapeutic inner ear drug levels and potential systemic toxicity (3, 4).
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 (5). As drug delivery vehicles, they offer intrinsic biocompatibility, low immunogenicity, and an innate ability to cross biological barriers.
Preclinical studies demonstrate that exosomes can be loaded with therapeutic agents, such as dexamethasone, and targeted to specific tissues, enhancing drug bioavailability and retention while minimizing off-target effects (6, 7).
The investigators hypothesize that IT administration of exosomes loaded with dexamethasone will result in superior therapeutic outcomes compared to conventional IT dexamethasone by improving perilymphatic pharmacokinetics, prolonging cochlear retention, and providing synergistic anti-inflammatory and cytoprotective effects via exosome-mediated signaling.
- Conditions
- Sensori-Neural Deafness, Exosomes
- Being tested
- exosomes derived from human umbilical cord mesenchymal stem cells
- Keywords
- Exosomes; SNHL; Dexamethasone
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomes derived from human umbilical cord mesenchymal stem cellsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants treated with dexamethasone Receives: Drug: exosomes derived from human umbilical cord mesenchymal stem cells |
| Intervention Group | Experimental | participants treated with exosomes Receives: Drug: exosomes derived from human umbilical cord mesenchymal stem cells |
| Intervention Group 2 | Experimental | participants treated with exosomes loaded with dexamethasone Receives: Drug: exosomes derived from human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start3 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensori-Neural DeafnessStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University, National Research Centre, Egypt
- Responsible party
- Principal investigator, Hussein A. El-Shirbeny, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568184
- Sponsor's protocol ID
- EXO-DEX-SSNHL-02
- Acronym
- EXO-DEX-SNHL
- Status last verified
- May 2026
- First submitted
- 25 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the final results
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07568184
- Acronym / sponsor ID
- EXO-DEX-SNHL / EXO-DEX-SSNHL-02
- Conditions
- Sensori-Neural Deafness, Exosomes
- Keywords
- Exosomes; SNHL; Dexamethasone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University, National Research Centre, Egypt
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To determine the safety and tolerability profile of IT Exo-Dex.
- 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.
- To assess changes in auditory function via Auditory Brainstem Response (ABR) thresholds and Otoacoustic Emissions (OAEs).
- 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).
Detailed description
SSNHL is defined as a rapid-onset hearing loss of ≥30 dB over at least three contiguous frequencies within a 72-hour period, with an incidence of 5-20 per 100,000 persons annually (1).
The idiopathic nature of most cases suggests multifactorial pathogenesis, including viral infections, autoimmune responses, and vascular ischemia, culminating in cochlear inflammation and oxidative stress (2).
The standard of care involves systemic corticosteroids, with salvage IT corticosteroid injections for non-responders. However, the blood-labyrinth barrier and the round window membrane pose significant anatomical and physiological barriers to effective drug delivery, resulting in sub-therapeutic inner ear drug levels and potential systemic toxicity (3, 4).
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 (5). As drug delivery vehicles, they offer intrinsic biocompatibility, low immunogenicity, and an innate ability to cross biological barriers.
Preclinical studies demonstrate that exosomes can be loaded with therapeutic agents, such as dexamethasone, and targeted to specific tissues, enhancing drug bioavailability and retention while minimizing off-target effects (6, 7).
The investigators hypothesize that IT administration of exosomes loaded with dexamethasone will result in superior therapeutic outcomes compared to conventional IT dexamethasone by improving perilymphatic pharmacokinetics, prolonging cochlear retention, and providing synergistic anti-inflammatory and cytoprotective effects via exosome-mediated signaling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: exosomes derived from human umbilical cord mesenchymal stem cellsParticipants treated with dexamethasone |
| Intervention Group | Experimental | Drug: exosomes derived from human umbilical cord mesenchymal stem cellsparticipants treated with exosomes |
| Intervention Group 2 | Experimental | Drug: exosomes derived from human umbilical cord mesenchymal stem cellsparticipants treated with exosomes loaded with dexamethasone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomes derived from human umbilical cord mesenchymal stem cellsExosomes (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. | Drug | Control Group, Intervention Group, Intervention Group 2 |
Primary outcome
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
Time frame: 6 months
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
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
Time frame: within six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. the final results
Related trials for Sensori-Neural Deafness
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exosomes derived from human umbilical cord mesenchymal stem cells in people with Sensori-Neural Deafness and Exosomes, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad Elzayat, PhD (+201012788746, Samoz9@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.