Premature Ovarian Failure Clinical Trial
Official title:
Transplantation of Specific Populations of Bone Marrow-Derived Stem Cells and Mesenchymal Stem Cells for the Treatment of Premature Ovarian Failure.
This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived specific populations of stem cells and mesenchymal stem cells injected into the ovaries (intraovarian injection), through a 12 week follow-up period. The investigators' chosen model of study is based on increasing the efficiency of the approach by choosing an autologous model which preserves the genetic composition of an individual that is vital in infertility conditions. Additionally the approach involves transplanting a combination of specific purified stem cell types which all aid in ovarian function recovery.
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cells are withdrawn and transplanted back into the patient on the same day of the procedure,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.
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|---|---|---|---|
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