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Autologous Bone Marrow Transplantation for Premature Ovarian Insufficiency (BMT-POI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02779374
Recruitment Status : Unknown
Verified October 2016 by Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University

Brief Summary:

Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.

Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency.

Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.


Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Other: Autologous bone marrow transplantation Not Applicable

Detailed Description:

Premature ovarian insufficiency (POI) has no curative treatment until now. It was noticed that some cases of POI to recover spontaneously. Furthermore, the concept of fixed prenatal pool of oogonia has been challenged and postnatal neo-oogenesis is currently proved.

Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal insufficiency. Data from animal studies showed that stimulation of these stem cells result in regeneration of the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.

Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency. These studies have been followed by researches on human being. Human studies included the use of stem cells from different sites including BM, adipose tissue, and umbilical cord.

Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Although studies proved that these newly developed oocytes to be genetically traced to the recipient; some other studies showed that the newly developed oocytes originate from the donor BM. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Use of autologous BMT also avoids the need for chemotherapy for conditioning and other related complications associated with allogeneic BMT. Human studies mostly used the ovarian injection of the BM. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Transplantation for Treatment of Premature Ovarian Insufficiency
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous bone marrow transplantation
autologous bone marrow will be given by intravenous infusion. the intervention will be preceded by a period of 6 months of follow up the a period of 12 months follow up
Other: Autologous bone marrow transplantation
Bone marrow aspiration of 10 ml/kg is done from the posterior iliac crest. The sample is put in sterile container with appropriate amount of heparin then filtered to remove bone spicules, fat, and cellular debris. The filtered sample is injected unprocessed in a peripheral vein. The process is done once.




Primary Outcome Measures :
  1. menses [ Time Frame: 6 months ]
    return of menses in a woman with previous ameneorrhea of at least 4 months before recruitment and during the 6 months of the pretest period


Secondary Outcome Measures :
  1. Pregnancy [ Time Frame: 12 months ]
    Occurrence of pregnancy during the period of 12 months of the post-test follow up

  2. FSH [ Time Frame: 12 months ]
    normalization of FSH (below 10 IU/L)

  3. Antimullarian hormone (AMH) [ Time Frame: 12 months ]
    normalization of AMH (above 0.9 ng/mL)

  4. follicular activity [ Time Frame: 12 months ]
    Growth of ovarian follicles to a size at least 18 mm in diameter

  5. Endometrial thickness [ Time Frame: 12 months ]
    Increase in endometrial thickness at least 8 mm.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with POI: For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).

Exclusion Criteria:

  • Abnormal karyotype
  • Previous pelvic or abdominal radiotherapy
  • Previous surgical management of ovarian pathology
  • Chronic disease: renal, liver, cardiac, malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779374


Locations
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Egypt
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department
Qena, Egypt
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: Mohammad AM Ahmed, MD Egypt, Qena, South Valley University, faculty of Medicine

Publications:
Dan S, Haibo L, Hong L. Pathogenesis and stem cell therapy for premature ovarian failure. OA Stem Cells 2014 Feb 10;2(1):4.
Edessy M, Hosni HN, Shady Y, Waf Y, Bakr S, Kamel M. Autologous stem cells therapy, the first baby of idiopathic premature ovarian failure. Acta Medica International. 2016;3(1):19-23.

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Responsible Party: Mohammad Abdel-Rahman Mohammad Ahmed, Doctor, South Valley University
ClinicalTrials.gov Identifier: NCT02779374    
Other Study ID Numbers: OBGYN002
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University:
ovarian insufficiency Bone Marrow
Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases