NCT06707389

Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

A Pilot Study of Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sudden Deafness
• Sensorineural Hearing Loss

Interventions

Type	Name	Description
BIOLOGICAL	autologous blood monocyte vesicles (lower dose)	20 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week.
DRUG	Methylprednisolone	40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Intratympanic injection of methylprednisolone was performed three times a week.
BIOLOGICAL	autologous blood monocyte vesicles (higher dose)	50 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week.

Timeline

• Start date: 2024-12-25
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-11-27
• Last updated: 2024-12-27