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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs Intravaginally | Experimental | Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Inravaginally |
|
| MSCs Laparoscopic | Experimental | Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Laparoscopic |
|
| EV | Experimental | Extravascular vesicles (EV) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| expanded autologous bone marrow derived MSC Intravaginally | Biological | Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of patients with positive ovarian changes |
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Inclusion Criteria:
Exclusion Criteria:
Married female
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| Name | Affiliation | Role |
|---|---|---|
| Dr Abdalla Awidi, MD | Cell therapy center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cell Therapy Center, University of Jordan | Amman | Jordan |
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|
| expanded autologous bone marrow derived MSC Laporoscopic | Biological | Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary |
|
| EV | Biological | Extracellular vesicles injection |
|
Patients ultrasounds of the ovaries will compare size and follicle numbers |
| 12 months |
| Number of patients with increased endometrial thickness | Ultrasounds of uterus will be compared for endometrial thickness | 12 months |
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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