Autologous Bone Marrow-Derived Stem Cell Transplantation in Patients With Premature Ovarian Failure (POF)
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|ClinicalTrials.gov Identifier: NCT03069209|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure||Biological: Stem Cells||Phase 1 Phase 2|
Premature ovarian failure (POF) is characterized as hypergonadotropic ovarian failure mostly prevalent before age 40. It is astonishingly frequent and affects around 1% of women below the age of 40. The clinical findings include amenorrhea and abnormally high levels of luteinizing (LH) and follicle stimulating hormone (FSH). The etiology of POF is unidentified in the majority of cases. It can occur due to a combination of genetics, immunological diseases, and environmental factors. POF is characterized by lack of secondary follicles, arrested folliculogenesis, decreased estrogen levels, and female infertility.
Currently, no available therapeutic intervention has been verified effective in retrieving fertility in patients with POF. Several trials at ovarian stimulation are typically ineffective. Consequently, the diagnosis of POF can cause great physical and emotional distress among patients. Hence, there is serious need to develop innovative treatment plans for POF.
The latest research shows that reduced ovarian reserve is caused by aging of the niche rather than a defect in germ cell lines. Current scientific evidence suggests that bone marrow-derived mesenchymal stem cells (BMSCs) could repair injured tissues and holds great promise in treating many diseases including male and female infertility.
The uniqueness of this study is demonstrated in the transplantation of purified specific populations of autologous bone marrow derived stem cells and mesenchymal stem cells (BMSCs) into patients with POF without in vitro expansion or culture, with minimal manipulation. Stem cells are withdrawn and transplanted back into the patient on the same day of the procedure, thus presenting the highest safety and efficacy parameters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Specific Populations of Bone Marrow-Derived Stem Cells and Mesenchymal Stem Cells for the Treatment of Premature Ovarian Failure.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Stem Cells
Intervention: Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.
Biological: Stem Cells
Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.
- Return of menstrual cycle [ Time Frame: 6 months ]Return of menses in a woman with previous ameneorrhea for at least 6 months before recruitment.
- Pregnancy [ Time Frame: 12 months ]Occurrence of pregnancy during the 12 months follow-up period
- FSH levels [ Time Frame: 12 months ]Normalization of FSH levels
- Follicular function [ Time Frame: 12 months ]development of ovarian follicles to a size at least 18 mm in diameter
- Endometrium thickness [ Time Frame: 12 months ]Increase in endometrial thickness
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): NCT03069209
|Stem Cells Arabia|
|Amman, Jordan, 11953|