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

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03069209
• Other study ID #: SCA-POF1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2015
• Est. completion date: January 2022

Study information

• Verified date: May 2018
• Source: Stem Cells Arabia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• Stem Cells
Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.

Locations

Country	Name	City	State
Jordan	Stem Cells Arabia	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cells Arabia

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return of menstrual cycle	Return of menses in a woman with previous ameneorrhea for at least 6 months before recruitment.	6 months
Secondary	Pregnancy	Occurrence of pregnancy during the 12 months follow-up period	12 months
Secondary	FSH levels	Normalization of FSH levels	12 months
Secondary	Follicular function	development of ovarian follicles to a size at least 18 mm in diameter	12 months
Secondary	Endometrium thickness	Increase in endometrial thickness	12 months