Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

Sudden deafness is a common emergency in otorhinolaryngology. As the etiology and mechanism of sudden deafness remains unknown, there is no specific treatment. Therefore, to explore new treatments for sudden deafness is a urgent and challenging problem. Extracellular vesicles therapy has been proved to be effective for several diseases. From our previous study, extracellular vesicles from mesenchymal stem cell can effectively improve noise-induced sensorineural deafness in mice. While mesenchymal stem cell therapy faces immune rejection in clinical use, the investigators use autologous blood monocyte vesicles to avoid immune rejection and guarantee patients' safety. In this interventional study, the investigators aimed to study the clinical effects and adverse reactions of autologous blood monocyte vesicle therapy in the treatment of sudden deafness. A total of 30 patients with severe or worse sudden deafness will enroll in this study and randomly assigned to 3 group, which are control group (Intratympanic glucocorticoid injection), lower-dose apoVs group (lower dose of Intratympanic monocyte vesicles injection) and higher-dose apoVs group (higher dose of Intratympanic monocyte vesicles injection). This study will further promote new treatment for sudden deafness and improve the quality of life and prognosis of patients with sudden deafness, especially those with severe or extremely severe deafness.

Eligibility criteria

Qualifiers

Patients aged between 18 and 65.

Patients with severe and above unilateral hearing loss who meet the diagnostic criteria for sudden deafness.

Patients who suffer sudden deafness within 3 weeks and do not receive intratympanic injection.

Patients who fully understand the purpose and requirements of the trial, volunteer to participate in the clinical trial, sign a written informed consent, and is willing to complete the whole trial process according to the trial requirements.

Disqualifiers

Patients with conductive deafness and mixed deafness;

Patients with other otologic diseases;

Those who have doubts about the treatment plan or have obvious mental and psychological disorders;

Patients with severe heart, lung, liver and kidney dysfunction;

Trial design

Treatments tested in this trial

  • autologous blood monocyte vesicles (lower dose)
  • Methylprednisolone
  • autologous blood monocyte vesicles (higher dose)

Treatment groups

30 Participants
are divided into 3 treatment groups

Locations

This trial has no locations