Autologous Blood Monocyte Vesicles for the Treatment of Sudden Deafness

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for sudden deafness, a condition that can occur unexpectedly and significantly affect hearing. The researchers aim to see if using vesicles (tiny particles) made from a patient’s own blood cells can help improve hearing in individuals who have experienced severe sudden deafness. By using a person's own cells, the study hopes to avoid issues like immune rejection, making the treatment safer. A total of 30 participants will be involved, and they will be divided into three groups: one will receive a standard treatment, while the others will receive different doses of the new vesicle therapy.

To be eligible for this trial, participants must be between 18 and 65 years old and have severe hearing loss that has occurred within the last three weeks. They should not have received any other treatments for their sudden deafness yet. Those with other ear diseases or serious health conditions, such as severe heart or kidney problems, may not qualify. If participants choose to join the trial, they can expect to receive careful monitoring throughout the process to assess both the effectiveness of the treatment and any potential side effects. This study represents an exciting step towards finding new options for individuals struggling with sudden hearing loss.

Gender

ALL

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.