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

NCT ID: NCT02372474

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-12-31

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).

Conditions

Premature Ovarian Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem Cell therapy in POF

POF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted.

Group Type: EXPERIMENTAL

Stem cell

Intervention Type: BIOLOGICAL

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).

Interventions

Stem cell

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).

Intervention Type: BIOLOGICAL

Other Intervention Names

- Edessy Stem cell Score.; - Laparoscopic stem cell transplantation.; - Hormonal Analysis; - Ultrasonic evaluation

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Edessy Mahmoud

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Edessy, Professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Hala N Hosni, Professor

Role: STUDY_CHAIR

Cairo University

Yousef Shdy, MD

Role: STUDY_CHAIR

Al-Azhar University

Syed Bkry, MD

Role: STUDY_CHAIR

Al-Azhar University

Medhat Kamel, Msc

Role: STUDY_CHAIR

Al-Azhar University

Locations

Al Azhar University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

M Edessy

Identifier Type: -

Identifier Source: org_study_id