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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04815213
Other study ID # POF.UJCTC
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 1, 2020
Est. completion date January 31, 2022

Study information

Verified date March 2021
Source University of Jordan
Contact Dr Hanan Jafar, PhD
Phone +96798871087
Email hanan.jafar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Jordan Cell Therapy Center, University of Jordan Amman

Sponsors (1)

Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death 12 months
Secondary Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes Efficacy will be measured comparing hormonal changes (FSH, LH, AMH, estradiol) in patients' blood on monthly intervals 12 months
Secondary Number of patients with positive ovarian changes Patients ultrasounds of the ovaries will compare size and follicle numbers 12 months
Secondary Number of patients with increased endometrial thickness Ultrasounds of uterus will be compared for endometrial thickness 12 months
See also
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