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

Primary Purpose

Premature Ovarian Failure

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Stem cell

About this trial

This is an interventional treatment trial for Premature Ovarian Failure focused on measuring POF, ESS, stem cell therapy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

Al Azhar University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell therapy in POF

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02372474

First Posted

January 12, 2015

Last Updated

February 25, 2015

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT02372474

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Ovarian Failure

Keywords

POF, ESS, stem cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stem Cell therapy in POF

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Stem cell

Other Intervention Name(s)

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

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.

Description

Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy.

Time Frame

128 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: