Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

NCT06707389 | Not Yet Recruiting Early Phase 1

• 1 other identifier: SYSKY-2023-1250-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Audiometry

  Pure tone audiometry.

  4 weeks after intervention.

Secondary Outcomes (5)

• Audiometry

  1 week, 2 weeks after intervention

• THI scale

  1 week, 2 weeks, 4 weeks after intervention.

• Tinnitus VAS

  1 week, 2 weeks, 4 weeks after intervention.

• SAS

  1 week, 2 weeks, 4 weeks after intervention.

• Adverse Events

  1 week, 2 weeks, 4 weeks after intervention.

Study Arms (3)

control

ACTIVE COMPARATOR

Intratympanic injection of methylprednisolone (methylprednisolone succinic acid for injection) at a dose of 40mg/mL, three times a week. 40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water.

Drug: Methylprednisolone

apoVs(lower dose)

EXPERIMENTAL

Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 20 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water.

Biological: autologous blood monocyte vesicles (lower dose)

apoVs(higher dose)

EXPERIMENTAL

Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 50 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water.

Biological: autologous blood monocyte vesicles (higher dose)

Interventions

autologous blood monocyte vesicles (lower dose) BIOLOGICAL

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.

apoVs(lower dose)

Methylprednisolone DRUG

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.

control

autologous blood monocyte vesicles (higher dose) BIOLOGICAL

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.

apoVs(higher dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with severe hematological diseases or tumors (especially those with acoustic neuromas);
• Those with positive HIV antibody, HBsAg, HCV antibody, or serological examination results for syphilis;
• Patients with a history of infection within 1 month prior to screening, requiring hospitalization and / or antibiotics, or currently using systemic hormones (corticosteroids), immunosuppressants or cytotoxicity;
• Patients with a history of immune system diseases or hematological system diseases;
• Patients with abnormal blood findings, such as abnormal number and morphology of red blood cells, white blood cells and platelets;
• Patients with severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine, and central nervous system diseases;
• Women during lactation, pregnancy, or possibly pregnancy;
• Patients with contraindications or allergies to the treatment of this study;
• Those who have participated in any clinical drug trial in the past 3 months;
• Patients that the Investigator considers unsuitable to participate in the trial;
• Patients not suitable for tympanic injection therapy.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Hearing Loss, Sudden; Hearing Loss, Sensorineural

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Yang Haidi, Doctor

CONTACT

13178821663; yanghd@mail.sysu.edu.cn

Huang Xiaotong

CONTACT

huangxt26@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: November 27, 2024
• Study Start: December 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12