Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

Not Applicable

Recruiting

• Conditions: Premature Ovarian Insufficiency
• Interventions: Procedure: autologous bone marrow cells injection

• Registration Number: NCT06302543
• Lead Sponsor: abdulmajeed hammadi

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-24
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bone marrow	autologous bone marrow cells injection	autologous bone marrow derived mononuclear cells injected 1cc per ovary for 2 ovaries under general anesthesia under ultrasound guide

Primary Outcome Measures

Name	Time	Method
change in gonadotropin levels	check every 4 weeks through study completion, an average of 1 year".	luteinizing hormone and follicular stimulating hormone are followed

Trial Locations

Locations (1)

Ministry of Health; 🇮🇶 Baghdad, Iraq