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NCT Number: NCT06707389

Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Audiometry

    Time frame: 4 weeks after intervention.

    Pure tone audiometry.

Secondary outcomes

  1. Audiometry

    Time frame: 1 week, 2 weeks after intervention

    Pure tone audiometry

  2. THI scale

    Time frame: 1 week, 2 weeks, 4 weeks after intervention.

    THI (tinnitus handicap inventory) is one of the most widely used tinnitus self-rating scales in the world.It consists of three dimensions: functional, emotional and severity and effect of decreased tinnitus on patients' daily life. The THI score is totally 100 points. The more score participants get, the severer tinnitus symtoms they suffer from. According to the total score, paticipants were divided into five grades, Grade I (0-16, light) , Grade II (18-36, mild) , Grade III (38-56, moderate) , grade IV (58-76, severe) , grade V (78-100, catastrophic).

  3. Tinnitus VAS

    Time frame: 1 week, 2 weeks, 4 weeks after intervention.

    The VAS(visual analogue scale) for subjective severity of tinnitus focuses on the subjective assessment of general sensation. The VAS has a scale score of 0 to 10, with 0 being completely unaffected and 10 being very severely affected.

  4. SAS

    Time frame: 1 week, 2 weeks, 4 weeks after intervention.

    The SAS(Self-Rating Anxiety Scale) consists of 20 items which reflect the subjective and feeling of Anxiety. The more score paticipants get, the more anxiety they suffer. The SAS score can be divided into 4 levels: normal(less than 50 score), mild anxiety(50-59 score), moderate anxiety(60-69 score) and severe anxiety(more than 69 score).

  5. Adverse Events

    Time frame: 1 week, 2 weeks, 4 weeks after intervention.

    Local adverse events include hearing loss, otitis media, and unperforation of tympanic membrane. Systemic adverse events include vital signs instability, new-onset anemia, liver and kidney dysfunction and so on. The severity of adverse events was graded according to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0, Grade 1: mild; asymptomatic or mild; clinical or diagnostic only; treatment free. Grade 2: Moderate; requiring small, local, or non-invasive treatment; limited instrumental daily living activities comparable to age. Grade 3: serious or medically significant but not immediately life threatening; hospitalization or prolonged hospitalization; disability; limited activities of daily life. Grade 4: life-threatening; requiring urgent treatment. Grade 5: Death related to AEs.

Study contacts

Contact information is provided by the study sponsor or research team.

Huang Xiaotong

CONTACT

[email protected]

Yang Haidi, Doctor

CONTACT

[email protected]

13178821663

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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