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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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160422027520N23
Enrollment
20
Registered
2024-02-21
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asherman syndrome (intrauterine adhesions). Complication associated with artificial fertilization, unspecified

Interventions

Intervention group: the group treated with EVs and the group receiving PBS (at least 20 people in each group).

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 44 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMirmohammadrezahosseini

Shahid Beheshti University of Medical Sciences

Seyed1448@gmail.com+98 937 597 0449

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026