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

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ClinicalTrials.gov Identifier: NCT04815213
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Hanan Jafar, University of Jordan

Study Description
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Brief Summary:
Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: BM-MSc


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    Patients ultrasounds of the ovaries will compare size and follicle numbers

  3. Number of patients with increased endometrial thickness [ Time Frame: 12 months ]
    Ultrasounds of uterus will be compared for endometrial thickness


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Married female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815213


Contacts
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Contact: Dr Hanan Jafar, PhD +96798871087 hanan.jafar@gmail.com

Locations
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Jordan
Cell Therapy Center, University of Jordan Recruiting
Amman, Jordan
Contact: Abdullah Aweidi, PhD         
Sponsors and Collaborators
University of Jordan
Investigators
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Study Chair: Dr Abdalla Awidi, MD Cell therapy center
More Information
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Responsible Party: Hanan Jafar, Vice director/ Cell therapy center, University of Jordan
ClinicalTrials.gov Identifier: NCT04815213    
Other Study ID Numbers: POF.UJCTC
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases