Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

NCT ID: NCT06302543

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-03-10

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.

Conditions

Premature Ovarian Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bone marrow

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

Group Type: EXPERIMENTAL

autologous bone marrow cells injection

Intervention Type: PROCEDURE

under general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection

Interventions

autologous bone marrow cells injection

under general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

abdulmajeed hammadi

INDUSTRY

Sponsor Role: lead

Responsible Party

abdulmajeed hammadi

clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ministry of Health

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

abdulmajeed hammadi, MD

Role: CONTACT

majeed51578@yahoo.co.uk

+9647902268105

bushra alazzawi, MD

Role: CONTACT

khaliljumakareem69@gmail.com

+9647705851195

Facility Contacts

abdulmajeed Hammadi, MD

Role: primary

alzaitounhospital@gmail.com

+9647902268105

Other Identifiers

POI bone marrow

Identifier Type: -

Identifier Source: org_study_id