Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

May 12, 2014 updated by: Sayed Bakry
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Sample of 60 ml is aspirated from the bone marrow of the iliac crest and prepared in the lab and injected in the ovaries through laparoscopy. Endometrial fractional biopsy was taken, stained with H&E stain and by IH staining by stem cell marker OCT4. Immunohistochemical expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). Participants were followed up monthly for a period of six months by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell marker OCT4 of the endometrial biopsy (stem cell positivity according to ESS) outcome.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menarche female less than 40 years old.
  • Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
  • Female with normal karyotyping.
  • Agree to sign the designed consent for the study.

Exclusion Criteria:

  • Pregnancy and lactation.
  • Autoimmune diseases.
  • Breast cancer, ovarian cancer.
  • Female with abnormal karyotyping (e.g. turner syndrome, fragile X syndrome….).
  • Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
  • Patients with secondary ovarian failure (e.g. hypothalamic causes)
  • Those with major medical problems such as malignancy, hepatitis, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem Cell Preparation and Injection

Stem Cell Preparation and Injection:

Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared and 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Cases
Time Frame: 48 Weeks
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Cases
Time Frame: 48 Weeks

Participants were followed up monthly(Every 4WKs) and Assessed by:

Hormonal Assessment. Clinical Assessment. Ultra Sound Assessment. Disappearance of Menopausal Symptoms. Pregnancy rate within 1 year. Miscarriage rate within one year of injection. Long term follow-up for any adverse effect, assessed for one year from injection.
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sayed Bakry

Collaborators

Cairo University
Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Mahmoud Edessy, MD, Al-Azhar University
  • Study Director: Sayed Bakry, PhD, Al-Azhar University
  • Study Chair: Hala Gabr, MD, Cairo University
  • Study Chair: Medhat Kamel, MSc, Al-Azhar University
  • Principal Investigator: Yehia Wafa, MD, Al-Azhar University
  • Study Chair: Hasan Tarabay, MD, Al-Azhar University
  • Study Chair: Youssef Abu Shady, MD, Al-Azhar University
  • Study Chair: Hala Hosni, MD, Cairo University
  • Study Chair: Wael Abu Elkhier, MD, Military Academy
  • Study Chair: Hamza El Tahan, BSc, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • M. Edessy, Hala N. Hosni, Y. Wafa, S Bakry, Y.Shady and M.Kamel. Stem Cells Transplantation in Premature Ovarian Failure.World Journal of Medical Sciences 10 (1): 12-16, 2014

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT223101547
  • AzharU223101547 (Registry Identifier: AzharU223101547)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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