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

Sponsor
University of Jordan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04815213
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: expanded autologous bone marrow derived MSC
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

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

Biological: expanded autologous bone marrow derived MSC
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
Other Names:
  • BM-MSc

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [12 months]

      Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death

    Secondary Outcome Measures

    1. Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes [12 months]

      Efficacy will be measured comparing hormonal changes (FSH, LH, AMH, estradiol) in patients' blood on monthly intervals

    2. Number of patients with positive ovarian changes [12 months]

      Patients ultrasounds of the ovaries will compare size and follicle numbers

    3. Number of patients with increased endometrial thickness [12 months]

      Ultrasounds of uterus will be compared for endometrial thickness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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. Clinically active autoimmune condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cell Therapy Center, University of Jordan Amman Jordan

    Sponsors and Collaborators

    • University of Jordan

    Investigators

    • Study Chair: Dr Abdalla Awidi, MD, Cell therapy center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanan Jafar, Vice director/ Cell therapy center, University of Jordan
    ClinicalTrials.gov Identifier:
    NCT04815213
    Other Study ID Numbers:
    • POF.UJCTC
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth
    Primary Ovarian Insufficiency
    Menopause, Premature

    Study Results

    No Results Posted as of Mar 24, 2021