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

Transplantation of Specific Populations of Bone Marrow-Derived Stem Cells and Mesenchymal Stem Cells for the Treatment of Premature Ovarian Failure.

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.

Study Overview

• Status: Unknown
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Biological: Stem Cells

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
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11953
    • Stem Cells Arabia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of menstrual cycle	Return of menses in a woman with previous ameneorrhea for at least 6 months before recruitment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Occurrence of pregnancy during the 12 months follow-up period	12 months
FSH levels	Normalization of FSH levels	12 months
Follicular function	development of ovarian follicles to a size at least 18 mm in diameter	12 months
Endometrium thickness	Increase in endometrial thickness	12 months

Collaborators and Investigators

• Sponsor: Stem Cells Arabia

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: February 25, 2017
• First Submitted That Met QC Criteria: February 25, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: SCA-POF1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided