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

University of Jordan

Status and phase: Active, not recruiting; Phase 1

Conditions: Premature Ovarian Failure

Treatments: Biological: expanded autologous bone marrow derived MSC Intravaginally; Biological: expanded autologous bone marrow derived MSC Laporoscopic; Biological: EV

Study type: Interventional

Funder types: Other

Identifiers

NCT04815213

POF.UJCTC

Details and patient eligibility

About

Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 3 patient groups

MSCs Intravaginally

Experimental group

Description:

Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Inravaginally

Treatment:

Biological: expanded autologous bone marrow derived MSC Intravaginally

MSCs Laparoscopic

Experimental group

Description:

Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Laparoscopic

Treatment:

Biological: expanded autologous bone marrow derived MSC Laporoscopic

EV

Experimental group

Description:

Extravascular vesicles (EV) injection

Treatment:

Biological: EV