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

NCT ID: NCT04815213

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2027-01-31

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.

Conditions

Premature Ovarian Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MSCs Intravaginally

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

Group Type: EXPERIMENTAL

expanded autologous bone marrow derived MSC Intravaginally

Intervention Type: BIOLOGICAL

Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

MSCs Laparoscopic

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

Group Type: EXPERIMENTAL

expanded autologous bone marrow derived MSC Laporoscopic

Intervention Type: BIOLOGICAL

Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

EV

Extravascular vesicles (EV) injection

Group Type: EXPERIMENTAL

EV

Intervention Type: BIOLOGICAL

Extracellular vesicles injection

Interventions

expanded autologous bone marrow derived MSC Intravaginally

Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

Intervention Type: BIOLOGICAL

expanded autologous bone marrow derived MSC Laporoscopic

Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

Intervention Type: BIOLOGICAL

EV

Extracellular vesicles injection

Intervention Type: BIOLOGICAL

Other Intervention Names

BM-MSc

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Hanan Jafar

Vice director/ Cell therapy center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Abdalla Awidi, MD

Role: STUDY_CHAIR

Cell therapy center

Locations

Cell Therapy Center, University of Jordan

Amman, , Jordan

Countries

Jordan

Other Identifiers

POF.UJCTC

Identifier Type: -

Identifier Source: org_study_id