A Pilot Study of Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Audiometry
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and
- •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.
排除标准
- •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.
研究组 & 干预措施
control
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.
干预措施: Methylprednisolone (Drug)
apoVs(lower dose)
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.
干预措施: autologous blood monocyte vesicles (lower dose) (Biological)
apoVs(higher dose)
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.
干预措施: autologous blood monocyte vesicles (higher dose) (Biological)
结局指标
主要结局
Audiometry
时间窗: 4 weeks after intervention.
Pure tone audiometry.
次要结局
- 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.)