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IRCT20160422027520N23 IRCT 2024-02-21 Tabriz University of Medical Sciences Investigating the effect of vesicle therapy and cell therapy in intrauterine adhesions 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) 2024-04-03 anticipated 20 Complete https://irct.ir/trial/75586 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. N/A Asherman syndrome (intrauterine adhesions). Intervention group: the group treated with EVs and the group receiving PBS (at least 20 people in each group). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: Doing research in this area Where to obtain: 09375970449 Mir Mohammad Reza Hosseini How to obtain: Send a request message through Iranian messengers to phone number 093759780449 Comments:
public Mirmohammadrezahosseini
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz
Tabriz Iran (Islamic Republic of) 1467864763 +98 937 597 0449 Seyed1448@gmail.com Shahid Beheshti University of Medical Sciences scientific Mehdi Yousefi
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 912 670 3953 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 20 years 44 years Female 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 N98.9 Complication associated with artificial fertilization, unspecified Treatment - Other Intervention group: the group treated with EVs and the group receiving PBS (at least 20 people in each group) 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. Tabriz University of Medical Sciences Approved 2023-12-04 Ethics committee of Tabriz University of Medical Sciences Golbad street Tabriz East Azarbaijan Iran (Islamic Republic of)