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The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans | Clinical Trials | Clareo Health

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

The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial

NCT04815213•University of Jordan

View on ClinicalTrials.gov

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

Age

18 - 38 years

Sex

FEMALE

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).
+1 more criteria

Locations (1)

Cell Therapy Center, University of Jordan

Amman, Jordan

Key Dates

Start Date

January 1, 2022

Primary Completion Date

January 31, 2025

Completion Date

January 31, 2027

Last Updated

January 28, 2025

Enrollment

ACTUAL participants

Conditions

Premature Ovarian Failure

Interventions

expanded autologous bone marrow derived MSC Intravaginally

BIOLOGICAL

expanded autologous bone marrow derived MSC Laporoscopic

BIOLOGICAL

Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?

NCT04390308

Infertility, FemalePremature Ovarian Failure+1 more

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UNKNOWN

Turner Syndrome Minipuberty Study

NCT04189406

Turner SyndromeInfertility, Female+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?

Turner Syndrome Minipuberty Study

Rejuvenation of Premature Ovarian Failure With Stem Cells

Autologous Bone Marrow Transplantation for Premature Ovarian Insufficiency

Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Endocan Levels in Women With Premature Ovarian Insufficiency