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NCT07878559

PHASE3

Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

Total-type sudden sensorineural hearing loss (defined in this study as severe-to-profound sudden sensorineural hearing loss with pure-tone average (PTA) \>70 dB HL) represents one of the poorer-prognosis subtypes of sudden sensorineural hearing loss (SSNHL). It is characterized by severe or profound sensorineural hearing decline occurring within 72 hours, frequently accompanied by tinnitus, aural fullness, vertigo and other symptoms. Although glucocorticoid-based comprehensive therapy has been widely applied in clinical practice, overall prognosis remains unsatisfactory for patients with total-type SSNHL, with low hearing recovery rates. Long-term hearing loss impairs verbal communication, sound source localization and quality of life, and is also associated with anxiety, depression and cognitive decline. Some patients further require hearing rehabilitation with hearing aids or auditory implantation, imposing substantial psychological and economic burdens on individuals and families. Therefore, exploring safer and more innovative therapeutic strategies carries important clinical significance. Extracellular vesicles (EVs) therapy is an emerging cell-free therapeutic technology. Previous pre-clinical studies have demonstrated that EVs can ameliorate inner-ear injury via anti-inflammatory, anti-oxidative-stress and neuroprotective effects, showing promising therapeutic potential in animal models of noise-induced and ototoxic drug-induced hearing loss. The investigators' prior research revealed that EV treatment effectively preserved hearing and alleviated cochlear damage in noise-deafened mice. Meanwhile, the investigators have completed a prospective, randomized exploratory clinical trial (NCT06707389). Its results indicated that intratympanic injection of extracellular vesicles (EVs) yielded favorable safety profiles in total-type SSNHL, without serious adverse events observed, and demonstrated a trend toward superior clinical benefits over conventional therapy in terms of hearing recovery and speech recognition improvement. Based on the above evidence, the investigators intend to conduct a multicenter, prospective, superiority-design randomized controlled clinical trial enrolling 146 patients with total-type SSNHL. This study will systematically evaluate the efficacy and safety of intratympanic autologous circulating extracellular vesicles (C-EVs) combined with glucocorticoid therapy, so as to provide new evidence-based medical data and therapeutic options for total-type SSNHL.

Official title: Comparison of Efficacy and Safety of Intratympanic Injection of Autologous Circulating Extracellular Vesicles Plus Glucocorticoid Versus Glucocorticoid Monotherapy for Total-Type Sudden Sensorineural Hearing Loss: A Multicenter, Superiority, Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2026-09-15

Completion Date

2030-03-31

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Sudden Sensorineural Hearing Loss (SSNHL)

Interventions

DRUG

autologous circulating extracellular vesicles

Intratympanic injection of autologous circulating extracellular vesicles combined with glucocorticoids

DRUG

Glucocorticoids

Intratympanic injection of glucocorticoids

Inclusion Criteria: 1. Aged ≥ 18 years old; 2. Patients with unilateral severe or profound hearing loss (\>70 dB HL) meeting the diagnostic criteria recommended by the Clinical Practice Guideline: Sudden Hearing Loss (2019) (United States); 3. Onset of sudden sensorineural hearing loss within 3 weeks; 4. Patients fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, sign the written informed consent form, and are willing to complete the entire trial process in accordance with trial requirements; 5. Enrolled patients shall receive inpatient treatment; for patients unable to be hospitalized, all clinical examination data must be complete; 6. All patients must have signed the informed consent form. Exclusion Criteria: 1. The affected ear has other deafness-causing factors, such as lateral skull-base tumor, trauma, drug ototoxicity, etc.; 2. Patients with concurrent conductive hearing loss or mixed hearing loss in the affected ear; 3. Patients with other comorbidities of the affected ear or pre-existing hearing loss; 4. Sudden unilateral or sequentially bilateral hearing loss (onset within several minutes to 3 days); 5. Patients with doubts about the treatment regimen or significant psychological-psychiatric disorders; 6. Patients with severe cardiac, pulmonary, hepatic or renal dysfunction, or those deemed unsuitable for this study by physician assessment; 7. Patients with middle-ear lesions, Ménière's disease, vestibular schwannoma, large vestibular aqueduct syndrome and other related diseases are excluded; 8. Patients with a history of infection within 1 month prior to screening requiring hospitalization and/or antibiotic therapy, or those currently receiving systemic glucocorticoids, immunosuppressants or cytotoxic therapy; 9. Women who are lactating, pregnant or planning to become pregnant; 10. Patients with contraindications or allergies to the study treatment; 11. Other patients unsuitable for intratympanic injection therapy.

Locations (1)

Otoendoscope

Guangzhou, Guangdong, China