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Autologous Bone Marrow-Derived Stem Cell Transplantation in Patients With Premature Ovarian Failure (POF)

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ClinicalTrials.gov Identifier: NCT03069209
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Brief Summary:
This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived specific populations of stem cells and mesenchymal stem cells injected into the ovaries (intraovarian injection), through a 12 week follow-up period. The investigators' chosen model of study is based on increasing the efficiency of the approach by choosing an autologous model which preserves the genetic composition of an individual that is vital in infertility conditions. Additionally the approach involves transplanting a combination of specific purified stem cell types which all aid in ovarian function recovery.

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Biological: Stem Cells Phase 1 Phase 2

Detailed Description:

Premature ovarian failure (POF) is characterized as hypergonadotropic ovarian failure mostly prevalent before age 40. It is astonishingly frequent and affects around 1% of women below the age of 40. The clinical findings include amenorrhea and abnormally high levels of luteinizing (LH) and follicle stimulating hormone (FSH). The etiology of POF is unidentified in the majority of cases. It can occur due to a combination of genetics, immunological diseases, and environmental factors. POF is characterized by lack of secondary follicles, arrested folliculogenesis, decreased estrogen levels, and female infertility.

Currently, no available therapeutic intervention has been verified effective in retrieving fertility in patients with POF. Several trials at ovarian stimulation are typically ineffective. Consequently, the diagnosis of POF can cause great physical and emotional distress among patients. Hence, there is serious need to develop innovative treatment plans for POF.

The latest research shows that reduced ovarian reserve is caused by aging of the niche rather than a defect in germ cell lines. Current scientific evidence suggests that bone marrow-derived mesenchymal stem cells (BMSCs) could repair injured tissues and holds great promise in treating many diseases including male and female infertility.

The uniqueness of this study is demonstrated in the transplantation of purified specific populations of autologous bone marrow derived stem cells and mesenchymal stem cells (BMSCs) into patients with POF without in vitro expansion or culture, with minimal manipulation. Stem cells are withdrawn and transplanted back into the patient on the same day of the procedure, thus presenting the highest safety and efficacy parameters.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Specific Populations of Bone Marrow-Derived Stem Cells and Mesenchymal Stem Cells for the Treatment of Premature Ovarian Failure.
Study Start Date : January 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stem Cells
Intervention: Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.
Biological: Stem Cells
Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.




Primary Outcome Measures :
  1. Return of menstrual cycle [ Time Frame: 6 months ]
    Return of menses in a woman with previous ameneorrhea for at least 6 months before recruitment.


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

  2. FSH levels [ Time Frame: 12 months ]
    Normalization of FSH levels

  3. Follicular function [ Time Frame: 12 months ]
    development of ovarian follicles to a size at least 18 mm in diameter

  4. Endometrium thickness [ Time Frame: 12 months ]
    Increase in endometrial thickness



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age : 20-39
  • FSH>20

Exclusion Criteria:

  • Thyroid dysfunction
  • Immunological Conditions
  • Past history of malignancy/cemotherapy/radiotherapy
  • Infectious diseases: HIV+, hepatitis B+, C+
  • Abnormal karyotype
  • Previous surgical management of ovarian pathology
  • Severe endometriosis

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): NCT03069209


Locations
Jordan
Stem Cells Arabia
Amman, Jordan, 11953
Sponsors and Collaborators
Stem Cells Arabia

Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT03069209     History of Changes
Other Study ID Numbers: SCA-POF1
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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