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Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Primary Purpose

Premature Ovarian Failure

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Stem Cell Preparation and Injection
Sponsored by
Sayed Bakry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Failure focused on measuring Primary Infertility, Primary Amenorrhea, Sex Steroid Deficiency, Premature Ovarian Failure (POF)

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell Preparation and Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement of Cases
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.

Secondary Outcome Measures

Improvement of Cases
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.

Full Information

First Posted
February 7, 2014
Last Updated
May 12, 2014
Sponsor
Sayed Bakry
Collaborators
Cairo University, Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02062931
Brief Title
Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
Official Title
Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sayed Bakry
Collaborators
Cairo University, Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
Primary Infertility, Primary Amenorrhea, Sex Steroid Deficiency, Premature Ovarian Failure (POF)

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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell Preparation and Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Stem Cell Preparation and Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of Cases
Description
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
Time Frame
48 Weeks
Secondary Outcome Measure Information:
Title
Improvement of Cases
Description
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.
Time Frame
48 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yehia Wafa, MD
Phone
+201223101547
Email
yehiawafa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sayed Bakry, PhD
Phone
+201006609978
Email
sayed.bakry@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Edessy, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yehia Wafa, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hasan Tarabay, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Youssef Abu Shady, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hala Hosni, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sayed Bakry, PhD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wael Abu Elkhier, MD
Organizational Affiliation
Military Academy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hala Gabr, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Medhat Kamel, MSc
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hamza El Tahan, BSc
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yehia Wafa, MD
Phone
+201223101547
Email
yehiawafa@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mahmoud Edessy, MD
Phone
+201005646785
Email
dredessy@gmail.com

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

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