Cell therapy using co-treatment mesenchymal stem cells with exosomes obtained from the umbilical cord in infertile women due to Asherman syndrome
Design
A controlled, parallel-group, unblinded, randomized, phase 2 clinical trial on 20 patients. Random assignment to intervention and control groups. The "Random Assignment Law" method was used for randomization.
Settings and conduct
This study is a clinical trial type. The study is divided into four groups of patients with Asherman syndrome referred to Al-Zahra Medical Education Center (S) in Tabriz who received treatment and the group of patients who did not receive treatment (each group at least 3 people who may There may be changes in the number as well). Standards of compliance with ethical principles and receiving informed consent form will be done from all the participants of the target groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 45 Be in low to medium stages of the disease. Have no blood pressure, diabetes, cardiovascular diseases They are not in menstruation or menopause Informed consent form Exclusion criteria: Patients under 20 years old and over 44 years old Patients with coagulation problems. Patients who have an underlying chronic disease and have to take special drugs.
Intervention groups
The group that received only mesenchymal stem cells.
The group that received only exosome.
The group that received mesenchymal stem cells and exosomes at the same time.
The group that received PBS as the control group.
Main outcome variables
Intrauterine adhesion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N26
Registration date:2025-01-11, 1403/10/22
Registration timing:retrospective
Last update:2025-01-11, 1403/10/22
Update count:0
Registration date
2025-01-11, 1403/10/22
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy using co-treatment mesenchymal stem cells with exosomes obtained from the umbilical cord in infertile women due to Asherman syndrome
Public title
Cell therapy based on exosomes obtained from umbilical cord in Asherman syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Secondary infertility or embryo transfer failure due to repeated IUA
Desire to become pregnant
Age less than 45 years old
consent to participate in the study
Exclusion criteria:
Patients under 20 years old and over 45 years old
Patients who themselves or their spouses have abnormal karyotype or genetic and chromosomal disorders
Patients with coagulation problems
Patients who have an underlying chronic disease and have to take special drugs
Patients whose HIV, HCV, or HBV test results are positive
Patients who have a history of asthma and allergies to certain drugs
Patients with intrauterine anomalies
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
The "Random Assignment Rule" method will be used for randomization:
1. Selection mechanism: Whenever a new participant enters the study, a third party randomly selects one of the sealed envelopes (not involved in the treatment process).
2. Concealment method: The envelopes must look the same, and no indication of the contents inside can be recognized from the outside. The envelopes must be opaque and sealed so that there is no possibility of tampering or viewing the contents before opening.
3. Allocation process: When the envelope is selected and opened, based on the number inside it (1 to 12), the participant is assigned to one of four groups:
Numbers 1 to 3: First intervention group
Numbers 4 to 6: Second intervention group
Numbers 7 to 9: Third intervention group
Numbers 10 to 12: Control group
4. Documentation: After opening each envelope, the card number and assigned group should be recorded to allow for tracking and monitoring of the randomization process.
This method will balance the number of people assigned to each group at the end of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad street
City
Tabriz
Province
East Azarbaijan
Postal code
516661476
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TBZMED.REC.1402.966
Health conditions studied
1
Description of health condition studied
Asherman syndrome (intrauterine adhesions)
ICD-10 code
N85.6
ICD-10 code description
Intrauterine synechiae
Primary outcomes
1
Description
Intrauterine adhesion rate
Timepoint
Before the intervention and after the intervention
Method of measurement
Using the ultrasound technique, we will evaluate the level of adhesion according to the standards of the American Fertility Association (AFS).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1 received a single-dose injection containing 1 x 10^7 mesenchymal stem cells. A subendometrial injection of a cell suspension, prepared in 1 ml of normal saline, was performed using a needle puncture (ovulation needle) at several points in the endometrium by a gynecologist on days 3 to 7 after menstruation.
Category
Treatment - Other
2
Description
Intervention Group 2: received two exosome injections at one-month intervals (40 µg/ml). Subendometrial injection of exosome suspension (prepared in 1 ml of normal saline) is performed using a needle puncture (ovulation needle) at several points in the endometrium by a gynecologist on days 3-7 after menstruation.
Category
Treatment - Other
3
Description
Intervention Group 3: received a single injection of 1 x 10^7 mesenchymal stem cells and two concurrent exosome injections at one-month intervals (40 µg/ml).
Category
Treatment - Other
4
Description
Control group: Single dose injection of phosphate-buffered saline (PBS). Intrauterine injection of PBS (1-2 ml) using an embryo transfer catheter performed by a gynecologist on days 3 to 7 after menstruation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Parvin Hakimi
Street address
Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 6658 1616
Email
parvin.hakimi56@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Daneshghah Streeet
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Daneshghah st
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Medical Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 413364665
Fax
Email
mehdi_yusefi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Doing research in this area
From where data/document is obtainable
Amir Valizadeh with contact number 09395502800
What processes are involved for a request to access data/document