Status:
ACTIVE_NOT_RECRUITING
The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans
Lead Sponsor:
University of Jordan
Conditions:
Premature Ovarian Failure
Eligibility:
FEMALE
18-38 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04815213
Start Date
January 1 2022
End Date
January 31 2027
Last Update
January 28 2025
Active Locations (1)
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1
Cell Therapy Center, University of Jordan
Amman, Jordan