Premature Ovarian Failure
Conditions
Brief summary
Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure
Detailed description
MSCs in passage-2 culture will be washed with PBS and detached with trypsin/EDTA (0.25%). After that, the cells will be suspended at a density of 20×106 cells/ 2 ml normal saline and loaded into 3 ml sterile syringes. The cells should be infused within 2 hours of release. Tests and follow up are to be monthly.
Interventions
BIOLOGICALexpanded autologous bone marrow derived MSC Intravaginally
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
BIOLOGICALexpanded autologous bone marrow derived MSC Laporoscopic
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
BIOLOGICALEV
Extracellular vesicles injection
Sponsors
University of Jordan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent 2. Married female, 18-38 years old 3. Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 20 IU/L) and/or Primary or secondary amenorrhea at least for 6 months 4. Evidence of low ovarian reserve defined as: AMH \< \_0.3 ng/ML & FSH \>20 IU/L, AFC \< 4, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder). 5. Normal karyotype 46, XX. 6. Presence of at least one ovary 7. Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels. 8. Agree to report any pregnancy to the research staff immediately. 9. Cooperative patient 10. Negative for infectious panel (HIV, HBV, HCV, and VDRL)
Exclusion criteria
1. Currently breast-feeding 2. Has a history of, or evidence of current malignancy 3. Major mental health disorder that precludes participation in the study 4. Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed. 5. Type I or Type II diabetes mellitus, or if receiving antidiabetic medications 6. Significant anemia (Hemoglobin \<8 g/dL). 7. Untreated deep venous thrombosis, and/or pulmonary embolus 8. Known heart disease (New York Heart Association Class II or higher). 9. Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)\>2 times normal, or total bilirubin \>2.5 mg/dL). 10. Known Renal disease (defined as Blood urea nitrogen (BUN)\>30 mg/dL or serum creatinine \> 1.6 mg/dL). 11. Clinically active autoimmune condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 12 months | Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes | 12 months | Efficacy will be measured comparing hormonal changes (FSH, LH, AMH, estradiol) in patients' blood on monthly intervals |
| Number of patients with positive ovarian changes | 12 months | Patients ultrasounds of the ovaries will compare size and follicle numbers |
| Number of patients with increased endometrial thickness | 12 months | Ultrasounds of uterus will be compared for endometrial thickness |
Countries
Jordan
Outcome results
None listed