The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans

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.

Inclusion criteria

• Signed and dated informed consent
• Married female, 18-38 years old
• 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
• 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).
• Normal karyotype 46, XX.
• Presence of at least one ovary
• Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
• Agree to report any pregnancy to the research staff immediately.
• Cooperative patient
• Negative for infectious panel (HIV, HBV, HCV, and VDRL)

Exclusion criteria

• Currently breast-feeding
• Has a history of, or evidence of current malignancy
• Major mental health disorder that precludes participation in the study
• 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.
• Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
• Significant anemia (Hemoglobin <8 g/dL).
• Untreated deep venous thrombosis, and/or pulmonary embolus
• Known heart disease (New York Heart Association Class II or higher).
• Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL).
• Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL).
• Clinically active autoimmune condition