Intra-ovarian Injection of MSC-EVs in Idiopathic Premature Ovarian Failure

Launched by ROYAN INSTITUTE · Jan 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a new treatment for women with premature ovarian failure (POF), a condition where the ovaries stop working before the age of 40. The treatment involves injecting tiny particles called extracellular vesicles (EVs) that come from special cells known as mesenchymal stem cells (MSCs) directly into the ovaries. These EVs are believed to help restore ovarian function without causing any harmful effects.

To be eligible for this trial, participants need to be women aged 20 to 38 who have been diagnosed with POF and have certain hormone levels indicating ovarian issues. They should have experienced a lack of menstrual periods for at least a year and must not have any serious health conditions that could complicate the treatment. If enrolled, participants can expect to receive the treatment and will be monitored closely for its safety and potential benefits. This trial is currently recruiting participants, and it's a chance to explore a new approach that could help women facing challenges related to early ovarian failure.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women between 20-38 years old
• • Baseline serum level of follicle stimulating hormone (FSH) higher or equal to 25 IU/l at least twice with an interval of 3 or 4 months
• • At least one year has passed since secondary amenorrhea and premature ovarian failure (POF) diagnosis
• • Normal karyotype and fragile X messenger ribonucleoprotein 1 (FMR1) gene
• Exclusion Criteria:
• • Primary amenorrhea
• • Congenital anomaly of the ovary
• • Thyroid disease Immune system diseases such as lupus, etc.
• • Previous and/or family history of ovarian tumor
• • Previous and/or family history of suffering from major diseases in the past and present such as cancer
• • Positive serological evidence regarding previous or current hepatitis B and C, Human T-lymphotropic virus 1, Human immunodeficiency virus (HIV), Syphilis Disturbance in the normal range of laboratory tests as levels of Hemoglobin Subunit Alpha 1 (HbA1), Alanine transaminase (ALT), The aspartate aminotransferase (AST), the number of white blood cells (WBCs), The creatinine (Cr), International normalised ratio (INR) , Platelets (Plt), Hematocrit (Hct) tests.
• • History of specific systemic disease (rheumatology, endocrine, cardiovascular, etc.)
• • Severe endometriosis (stage III and IV)
• • Small and non-injectable ovaries Lack of patient satisfaction
• • The patient's unwillingness to continue participating in the study