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IRCT20130812014333N255 IRCT 2025-06-20 Kermanshah University of Medical Sciences Efficacy of exosome-impregnated paper patches in myringoplasty of patients with ruptured eardrums Efficacy of exosome-impregnated paper patches in myringoplasty of patients with ruptured eardrums 2025-06-20 anticipated 60 Complete https://irct.ir/trial/84256 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Tympanic Membrane Perforation. In the intervention group, paper patches impregnated with exosomes derived from umbilical cord mesenchymal stem cells (UC-MSCs) will be used in myringoplasty surgery to treat patients with ruptured eardrums.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Taha Araghi
Imam Khomeini Hospital, Street of Naghliyeh
Kermanshah Iran (Islamic Republic of) 00988337283602 6718743161 t.araghi@yahoo.com Kermanshah University of Medical Sciences scientific Dr. Kamran Mansouri
Medical Biology Research Center, Faculty of Medicine, Nurse Blvd.
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 kmansouri@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Informed consent Patients diagnosed with a perforated tympanic membrane Age between 18-65 years Patients who have no contraindications to regenerative therapy or stem cell-derived therapies and no history of autoimmune diseases or immunodeficiency conditions that could interfere with the effects of exosome therapy. 18 years 65 years Both Patients with chronic middle ear infections who do not respond to standard treatments Pregnant or breastfeeding women Patients who are currently enrolled in other clinical trials involving regenerative or stem cell therapies or have a history of allergic reactions to stem cell-derived products or any of the therapeutic ingredients. H72 Perforation of tympanic membrane Treatment - Other In the intervention group, paper patches impregnated with exosomes derived from umbilical cord mesenchymal stem cells (UC-MSCs) will be used in myringoplasty surgery to treat patients with ruptured eardrums. Repair of a ruptured eardrum. Timepoint: One, three and six months after treatment. Method of measurement: Using tympanometry and audiometry. Kermanshah University of Medical Sciences Approved 2025-05-13 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)