Clinical Phase I and IIa Trials of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Pure tone test
研究概览
简要总结
The goal of this clinical trial is to learn if small extracellular vesicles derived from mesenchymal stem cells work to treat severe and above sudden sensorineural hearing loss. It will also learn about the safety of small extracellular vesicles. The main questions it aims to answer are:
- Does small extracellular vesicles combined with traditional drug treatment improve hearing even better in severe and above sudden deafness participants?
- What medical problems do participants have with intratympanic injection of small extracellular vesicles? Researchers will compare small extracellular vesicles to dexamethasone to see if small extracellular vesicles work to treat severe and above sudden sensorineural hearing loss.
In clinical Phase I trial, the investigators will complete the safety check and dose exploration.
Participants will:
- Receive traditional drug treatment in accordance with the "Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)
- Receive small extracellular vesicles or a placebo tympanic injection additionally
- Visit the clinic once every 2 weeks for checkups and tests
- Receive tympanic injections of small extracellular vesicles ranging from low concentration to high concentration
- Be evaluated for any adverse reactions In clinical Phase II trial, participants were randomly divided into a control group and an experimental group.
Participants will: 6. Received intratympanic injections of small extracellular vesicles 3 times together with traditional drug treatment in experimental group 7. Received intratympanic injections of 5mg dexamethasone 3 times together with traditional drug treatment in control group, also for a total of 3 times Visit the clinic once 7 days , 1month and 3 months after treatment for checkups and tests of pure tone audiometry, speech audiometry, tinnitus disability scale and visual analogue scale assessment
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
- Double (Participant, Investigator)
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
- •Sudden unilateral hearing loss that occurs within 72 hours, with a decrease of at least 30 decibels in at least 3 frequency ranges compared to the healthy ear, and an average pure tone threshold of ≥ 65 decibels.
- •Enrollment must be completed within 7 days after the onset of sudden deafness.
- •Men or women aged 18 to 65
- •Not treated in any other hospital and not taking any treatment medication on one's own
- •Be able to understand the trial protocol and undergo regular follow-up visits and check-ups
排除标准
- •Pregnant or lactating women
- •With a history of chronic ear diseases, ear surgery, autoimmune hearing loss or a confirmed diagnosis of Meniere's syndrome in the past
- •Having received steroid treatment for any reason within the past 30 days
- •There are autoimmune diseases or chronic inflammatory diseases.
- •Severe damage to liver and kidney functions
- •Patients with a previous history of cerebral hemorrhage or those currently taking anticoagulant medications
- •Other cases in which the researchers judged the candidates to be unsuitable for inclusion
研究组 & 干预措施
Treatment group-Clinical Phase I
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at low to high dose
干预措施: Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at three different doses (Drug)
Control Group--Clinical Phase II
Standard treatment for sudden deafness+dexamethasone
干预措施: Standard treatment for sudden deafness+dexamethasone (Drug)
Control Group--Clinical Phase I
Standard treatment for sudden deafness+hUC-MSC-sEV-003 mimetics
干预措施: Standard treatment for sudden deafness+hUC-MSC-sEV-003 mimetics (Drug)
Treatment Group--Clinical Phase II
Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by the stage I trial
干预措施: Standard treatment for sudden deafness+hUC-MSC-sEV-003 at an appropriate dose as determined by stage I trial (Drug)
结局指标
主要结局
Pure tone test
时间窗: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
The hearing recovery status is evaluated based on the changes in pure tone threshold from the baseline at enrollment to 3 months of follow-up. The pure tone threshold is the average of air conduction thresholds at 0.25, 0.5, 1, 2, 4 kHz, and 8 kHz.
speech audiometry
时间窗: Baseline,7 days,1 month, and 3 months after clinical phase II treatment
The hearing recovery status is also evaluated based on the changes in speech recognition rate from the baseline at enrollment to 3 months of follow-up. The speech audiometry results use the speech recognition rates at the baseline and after treatment of the subjects.
次要结局
- tympanic membrane healing status(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Respiration(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Heart rate(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Oxygen saturation(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Blood pressure(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Haematological index on liver function(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Haematological index on kidney function(Baseline, 2 weeks after intratympanic injection in the first-phase clinical)
- Tinnitus Handicap Inventory(Baseline,7 days,1 month, and 3 months after clinical phase II treatment)
- Visual Analogue Scale(Baseline,7 days,1 month, and 3 months after clinical phase II treatment)
研究者
jiangyan
Chief Physician
The Affiliated Hospital of Qingdao University