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

Al-Azhar University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Premature Ovarian Failure

Treatments: Biological: Stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02372474

M Edessy

Details and patient eligibility

About

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

Full 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).

Enrollment: 112 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Stem Cell therapy in POF

Experimental group

Description:

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

Treatment:

Biological: Stem cell