Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
10
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
Extracellular vesicles injection
Cell Therapy Center, University of Jordan
Amman, Jordan
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
Time frame: 12 months
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
Time frame: 12 months
Number of patients with positive ovarian changes
Patients ultrasounds of the ovaries will compare size and follicle numbers
Time frame: 12 months
Number of patients with increased endometrial thickness
Ultrasounds of uterus will be compared for endometrial thickness
Time frame: 12 months
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