Autologous Bone Marrow-Derived Stem Cell Transplantation in Patients With Premature Ovarian Failure (POF)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transplantation of Specific Populations of Bone Marrow-Derived Stem Cells and Mesenchymal Stem Cells for the Treatment of Premature Ovarian Failure.

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age : 20-39 FSH>20 Exclusion Criteria: Thyroid dysfunction Immunological Conditions Past history of malignancy/cemotherapy/radiotherapy Infectious diseases: HIV+, hepatitis B+, C+ Abnormal karyotype Previous surgical management of ovarian pathology Severe endometriosis

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells<br>Intervention: Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells. | Biological: Stem Cells<br>* Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of menstrual cycle | Return of menses in a woman with previous ameneorrhea for at least 6 months before recruitment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Occurrence of pregnancy during the 12 months follow-up period | 12 months | 
| FSH levels | Normalization of FSH levels | 12 months | 
| Follicular function | development of ovarian follicles to a size at least 18 mm in diameter | 12 months | 
| Endometrium thickness | Increase in endometrial thickness | 12 months |