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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03069209
Other study ID # SCA-POF1
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Completed NCT00417066 - Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders Phase 4
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Completed NCT03840824 - Blood Spot Self-administered Test and Assay
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Not yet recruiting NCT04390308 - Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Completed NCT02783937 - Filgrastim for Premature Ovarian Insufficiency Phase 4
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Completed NCT00429494 - GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients Phase 2
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Not yet recruiting NCT04306185 - Ovarian Fragmentation Study (Crespo Medical Team) N/A
Recruiting NCT02062931 - Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure Phase 1/Phase 2
Completed NCT02151890 - Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure Phase 1/Phase 2