Investigating the effect of intrauterine injection of Extracellular vesicles derived from human umbilical cord Wharton's Jelly mesenchymal stem cells in the healing process of women with intrauterine adhesions(Asherman syndrome)
Determination of the effect of intrauterine injection of extracellular vesicles derived from Wharton jelly mesenchymal stem cells of human umbilical cord in the healing process of women with intrauterine adhesions (Asherman syndrome)
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 20 patients. A table of random numbers was used for randomization.
Settings and conduct
The study is a clinical trial type. The study is divided into two groups of patients with Asherman's syndrome referred to Valiasr Hospital in Tabriz who received treatment and the group of patients who did not receive treatment (each group is at least 20 people and there may be changes in the number of faces during the work process) take). 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 44
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 treated with EVs
The group receiving PBS
Main outcome variables
Expecting the improvement of the macroscopic conditions of the uterus in terms of adhesion, bleeding and inflammation indicators, pathological indicators including the thickness of the endometrial tissue, the number of endometrial glands, the extent of fibrosis and the amount of endometrial angiogenesis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N23
Registration date:2024-02-21, 1402/12/02
Registration timing:prospective
Last update:2024-02-21, 1402/12/02
Update count:0
Registration date
2024-02-21, 1402/12/02
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
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intrauterine injection of Extracellular vesicles derived from human umbilical cord Wharton's Jelly mesenchymal stem cells in the healing process of women with intrauterine adhesions(Asherman syndrome)
Public title
Investigating the effect of vesicle therapy and cell therapy in intrauterine adhesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 44 whose disease has been proven
be in low to medium stages of the disease
have no blood pressure, diabetes, cardiovascular diseases and other underlying problems
Not during menstruation or menopause
Their cycles during treatment should preferably be close to each other
have filled out the informed consent form
Do not have any history of immunotherapy
Exclusion criteria:
Patients under 20 years old and over 44 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 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The cooperation of obstetrics and gynecology specialists, groups with Asherman syndrome who were between the ages of 20 and 44 and who visited the hospital and did not have problems such as early menopause, serious diseases such as coagulation problems, liver and kidney diseases, and polyps, myoma, and septum. will be selected for treatment. Patients are divided into two groups. The group treated with EVs and the group receiving PBS (at least 20 people in each group)
This division will be hidden from the participants
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
2023-12-04, 1402/09/13
Ethics committee reference number
IR.TBZMED.REC.1402.657
Health conditions studied
1
Description of health condition studied
Asherman syndrome (intrauterine adhesions)
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Intrauterine adhesion rate
Timepoint
Before the intervention and after the intervention
Method of measurement
Initial examinations of referring patients (through history, initial ultrasound and blood sample testing) will be done. Then, the stem cells derived from Wharton's umbilical cord jelly (WJ-MSC) will be prepared and cultivated and their identity will be determined to extract extracellular vesicles (using a separation kit or ultracentrifuge technique). Characteristics of extracellular vesicles, including determining the concentration, size and percentage of extracellular vesicles, will be obtained using BCA, DLS, electron microscope photography, and will be ready for injection after confirmation. We will evaluate the related tests using the ultrasound technique, the amount of adhesion, fibrosis, uterine thickness, uterine length and menstrual cycle according to the American Fertility Association (AFS) standards. We will examine blood leukocytes, lipid, sugar and enzyme markers. A tissue biopsy is performed and the amount of fibrosis, tissue collagen and the amount of adhesion are checked using Masson trichrome and H/E tissue staining. We will evaluate the expression level of SMA marker in the uterine endometrial tissue section using Real Time PCR technique.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the group treated with EVs and the group receiving PBS (at least 20 people in each group)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr International Hospital, Tabriz
Full name of responsible person
Shahla Danai
Street address
Valiasr Hospital, Zafaranieh street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 6658 1616
Email
danaiish@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
Tabriz University of Medical Sciences, Daneshghah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 912 670 3953
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mirmohammadrezahosseini
Position
Master of Medical Immunology
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
Tehran
Postal code
1467864763
Phone
+98 937 597 0449
Email
Seyed1448@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 912 670 3953
Email
yousefime@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mir Mohammad Reza Hosseini
Position
Master of Medical Immunology
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Shahrake Gharb
City
Tehran
Province
Tehran
Postal code
1467864763
Phone
+98 937 597 0449
Email
Seyed1448@gmail.com
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
09375970449 Mir Mohammad Reza Hosseini
What processes are involved for a request to access data/document
Send a request message through Iranian messengers to phone number 093759780449