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

Phase 1

Completed

• Conditions: Premature Ovarian Failure
• Interventions: Biological: Stem cell

• Registration Number: NCT02372474
• Lead Sponsor: Al-Azhar University

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-01-12
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell therapy in POF	Stem cell	POF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted.

Primary Outcome Measures

Name	Time	Method
Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.	128 weeks	Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy.

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Egypt