Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

Official title

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

Overview

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.

Interventions

• 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
• 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

Primary outcome measures

• Audiometry [Time frame: 4 weeks after intervention.]

Secondary outcome measures (5)

• Audiometry [Time frame: 1 week, 2 weeks after intervention]
• THI scale [Time frame: 1 week, 2 weeks, 4 weeks after intervention.]
• Tinnitus VAS [Time frame: 1 week, 2 weeks, 4 weeks after intervention.]
• SAS [Time frame: 1 week, 2 weeks, 4 weeks after intervention.]
• Adverse Events [Time frame: 1 week, 2 weeks, 4 weeks after intervention.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06707389 · SYSKY-2023-1250-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗