It is a Real The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure

Study Overview
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Brief Summary
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The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.

Detailed Description
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Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They are self sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop in many different cell types in the body. Premature ovarian failure (POF) is the loss of ovarian function in women less than 40 years. It is associated with sex steroid deficiency, amenorrhea, infertility, and elevated serum gonadotropins. This work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al- Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was laparoscopically injected in the ovaries. Endometrial fractional biopsy is histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to Edessy stem cells score (ESS) (1).

Official Title
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It is a Real The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: Stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menarche female less than 40 years old. Normal karyotyping female. Primary ovarian failure females Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L. Agree to sign the designed consent for the study. Exclusion Criteria: Autoimmune diseases. Breast cancer, ovarian cancer. Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs. Those with major medical problems such as malignancy, hepatitis, etc.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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 Cell therapy in POF<br>POF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted. | Biological: Stem cell<br>* Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).<br>* Other names: - Ultrasonic evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF. | Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy. | 128 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POF, ESS, stem cell therapy