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

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372474
• Other study ID #: M Edessy
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 12, 2015
• Last updated: February 25, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• 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).

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes