Clinical trial NCT04815213: The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans
Official title: The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Premature Ovarian Failure
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes
timeFrame: 12 months
measure: Number of patients with positive ovarian changes
timeFrame: 12 months
measure: Number of patients with increased endometrial thickness
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center, University of Jordan
Study officials:
affiliation: Cell therapy center
name: Dr Abdalla Awidi, MD
role: STUDY_CHAIR
References: