Exosome-impregnated paper patches in myringoplasty of patients with eardrum rupture
Design
This is a non- blindedrandomized clinical trial with a parallel design. This study will be conducted on at least 60 eligible patients and patients will be placed in the intervention group.
Settings and conduct
This study, which will be conducted at Imam Khomeini Hospital in Kermanshah, is non-blinded. The purification and isolation process of exosomes derived from umbilical cord mesenchymal stem cells will be performed at the Regenerative Medicine Center of Kermanshah University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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.
Exclusion criteria:Patients with chronic middle ear infections who do not respond to standard treatments;Pregnant or breastfeeding women; b.
; 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.
Intervention groups
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.
Main outcome variables
Repair of a ruptured eardrum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N255
Registration date:2025-06-20, 1404/03/30
Registration timing:registered_while_recruiting
Last update:2025-06-20, 1404/03/30
Update count:0
Registration date
2025-06-20, 1404/03/30
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-20, 1404/03/30
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of exosome-impregnated paper patches in myringoplasty of patients with ruptured eardrums
Public title
Efficacy of exosome-impregnated paper patches in myringoplasty of patients with ruptured eardrums
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-05-13, 1404/02/23
Ethics committee reference number
IR.KUMS.REC.1404.139
Health conditions studied
1
Description of health condition studied
Tympanic Membrane Perforation
ICD-10 code
H72
ICD-10 code description
Perforation of tympanic membrane
Primary outcomes
1
Description
Repair of a ruptured eardrum
Timepoint
One, three and six months after treatment
Method of measurement
Using tympanometry and audiometry
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hojat Sargazi
Street address
Imam Khomeini Hospital, Street of Naghliyeh
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
hojatsargazi43@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Zohreh Rahimi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
Zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Taha Araghi
Position
A member of the university faculty
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini Hospital, Street of Naghliyeh
City
Kermanshah
Province
Kermanshah
Postal code
00988337283602
Phone
6718743161
Email
t.araghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
A member of the university faculty
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Medical Biology Research Center, Faculty of Medicine, Nurse Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
kmansouri@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hojat Sargazi
Position
Otolaryngology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini Hospital, Street of Naghliyeh
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
hojatsargazi43@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD