Intra-ovarian injection of stem cell-derived vesicles for premature ovarian failure
Safety and Feasibility Study of Intra-ovarian Injection of Bone Marrow Mesenchymal Stromal Cells-derived Extracellular Vesicles in Idiopathic Premature Ovarian Failure Patients: Clinical Trial Phase I
This study is testing if injecting special cell-made vesicles into the ovaries can help women with premature ovarian failure improve hormone levels and possibly restore their menstrual cycles.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 38 Years |
| Sex | Female |
| Sponsor | Royan Institute Government |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06202547 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intra-ovarian injections of extracellular vesicles derived from mesenchymal stromal cells on women diagnosed with premature ovarian failure. The study aims to evaluate changes in hormone levels, specifically Follicle-Stimulating Hormone (FSH) and Anti-Mullerian Hormone (AMH), as well as the potential restoration of menstrual cycles over an 8-month follow-up period. A total of 10 eligible patients will receive the treatment, and their responses will be monitored for any side effects or complications. The trial is designed to provide insights into a novel therapeutic approach for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20-38 with a diagnosis of premature ovarian failure and elevated FSH levels.
Not a fit: Patients with primary amenorrhea, congenital ovarian anomalies, or significant immunological and cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could restore ovarian function and menstrual cycles in women suffering from premature ovarian failure.
How similar studies have performed: While there have been studies on the use of stem cell-derived therapies, this specific approach using MSC-derived extracellular vesicles in premature ovarian failure is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tehran
- Royan Institute — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Faezeh Shekari, Ph.D — Department of Development of Stem Cell Sciences of Royan Institute
- Study coordinator: Parvaneh Afsharian, Ph.D
- Email: p.afsharian@royan-rc.ac.ir
- Phone: +9802123562674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.