Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

Premature Ovarian Insufficiency Clinical Trial

— alfarah  

Official title:

Treatment of Premature Ovarian Insufficiency Using Autologous Bone Marrow Concentrates Through Transvaginal Approach Under Ultrasound Guidance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302543
• Other study ID #: POI bone marrow
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 24, 2024

Study information

• Verified date: March 2024
• Source: Global Stem Cell Center, Baghdad
• Contact: abdulmajeed hammadi, MD
• Phone: +9647902268105
• Email: majeed51578[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.

Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program.

Description:

Premature ovarian insufficiency is a clinical syndrome characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotrophin hormones and low estrogen and anti-Mullerian hormone. The average age for menopause is 50-52 years in the developed world ,it is believed that about 1% for women less than 40 years of age and 0.1 in less than 30 years of age has premature ovarian insufficiency.

Etiology of POI may be genetic, chromosomal, or auto immune.in addition to cancer treatment and surgical causes.

Hormonal replacement therapy is recommended for POI patients to alleviate vasomotor symptoms in addition to prevent osteoporosis and ischemic heart disease.

Regenerative medicine is a new medical approach to treat variety of diseases involving many tissues or organs in human body using cells, biological products instead of drugs or physical factors.

Autologous use of stem cells from bone marrow or adipose tissue (stromal vascular fraction) or platelet rich plasma are alternative safe minimal manipulative products that can provide a solution to this clinical syndrome.

Only few cases had been mentioned in the literature offering autologous stem cells for treating POI including bone marrow or adipose derived stem cells in addition to mesenchymal stem cells expanded invitro.

the investigator use autologous bone marrow concentrate with transvaginal approach under ultrasound guidance to treat POI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 24, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

1. clinical diagnosis of premature Ovarian insufficiency.

2. ineffective hormonal therapy.

3. biochemical evidence of high gonadotropins.

Exclusion criteria:

1. solid or hematological malignancies.

2. bleeding disorders.

3. rejection of the procedure.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• autologous bone marrow cells injection
under general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection

Locations

Country	Name	City	State
Iraq	Ministry of Health	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
abdulmajeed hammadi

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in gonadotropin levels	luteinizing hormone and follicular stimulating hormone are followed	check every 4 weeks through study completion, an average of 1 year".