About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
clinical diagnosis of premature Ovarian insufficiency.
ineffective hormonal therapy.
biochemical evidence of high gonadotropins.
Disqualifiers
solid or hematological malignancies.
bleeding disorders.
rejection of the procedure.
Trial design
Single group
Treatments tested in this trial
autologous bone marrow cells injection
Procedure/Surgeryunder general anesthesia bone marrow aspiration done followed by cell concentration and transvaginal ovarian injection
Treatment groups
Trial outcomes
Primary outcomes
change in gonadotropin levels
luteinizing hormone and follicular stimulating hormone are followed
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
abdulmajeed hammadi
Lead sponsor
Global Stem Cell Center, Baghdad
Sponsor institution