Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302543
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-24
Brief Title:
Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells
Sponsor:
abdulmajeed hammadi
Organization:
Global Stem Cell Center Baghdad
Study Overview
Official Title:
Treatment of Premature Ovarian Insufficiency Using Autologous Bone Marrow Concentrates Through Transvaginal Approach Under Ultrasound Guidance
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
alfarah
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
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 01 in less than 30 years of age has premature ovarian insufficiency
Etiology of POI may be genetic chromosomal or auto immunein 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
Etiology of POI may be genetic chromosomal or auto immunein 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None