Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Summary

Stem cells (SC) are the foundation cells for every organ, tissue and cell in the body. They are undifferentiated "blank" cells that do not yet have a specific function. Under proper conditions, they begin to develop into specialized tissue and organs. They are self-sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop into many different cell types in the body. They serves as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person is still alive. 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. POF occurs in 1 % of women. In majority of cases the underlying cause is not identified. Management essentially involves hormone replacement and infertility treatment. This work aimed to evaluate the therapeutic potential of Autologous MSC transplantation in women suffering from Premature Ovarian Failure.

Conditions

• Premature Ovarian Failure

Interventions

BIOLOGICAL

Stem Cell Preparation and Injection

Stem Cells 60 ml of bone marrow will aspirated using local anathesia and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared. Blood sample drawn from venous blood centrifuged and then platelets rich plasma (PRP) collected. The purified and collected stem cells suspended in platelets rich plasma (PRP) using GMP rules and finally injected into ovarian tissues and ligaments . Stem Cell Dose: 3-5 Million Autologous MSCs Injected into Ovarian tissue.

Sponsors & Collaborators

• Cairo University

  collaborator OTHER

• Affiliated Hospital to Academy of Military Medical Sciences

  collaborator OTHER

• Sayed Bakry

  lead OTHER

Principal Investigators

• Mahmoud Edessy, MD · Al-Azhar University

• Yehia Wafa, MD · Al-Azhar University

• Hasan Tarabay, MD · Al-Azhar University

• Youssef Abu Shady, MD · Al-Azhar University

• Hala Hosni, MD · Cairo University

• Sayed Bakry, PhD · Al-Azhar University

• Wael Abu Elkhier, MD · Military Academy

• Hala Gabr, MD · Cairo University

• Medhat Kamel, MSc · Al-Azhar University

• Hamza El Tahan, BSc · Al-Azhar University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2015-05-31

Completion

2016-11-30

Countries

• Egypt

Study Locations