Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132542
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-07
Brief Title:
Autologous ADMSC Transplantation in Patients With POI
Sponsor:
Mongolian National University of Medical Sciences
Organization:
Mongolian National University of Medical Sciences
Study Overview
Official Title:
Autologous Adipose Derived Mesenchymal Stromal Cell Transplantation in Patients With Idiopathic or Drug Induced Premature Ovarian Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
ADMSC
Brief Summary:
The primary ovarian insufficiency premature ovarian failure premature ovarian insufficiency premature menopause is a hypergonadotropic hypogonadism that failure of the ovarian function in woman younger than 40 years Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration
We are planning to investigate the effectiveness of adipose stem cell on ovarian tissue regeneration for patients with premature ovarian failure
We are planning to investigate the effectiveness of adipose stem cell on ovarian tissue regeneration for patients with premature ovarian failure
Detailed Description:
The primary ovarian insufficiency premature ovarian failure premature ovarian insufficiency premature menopause is a hypergonadotropic hypogonadism that failure of the ovarian function in woman younger than 40 years Ovary is a important organ of reproduction as well as endocrine organ that secretes estrogen and progesterone to stimulate the endometrium and other organs The main features of are sex hormone deficiency amenorrhea infertility and elevated serum gonadotropins
This condition occurs in approximately 1 of women and it has significant psychological and physical consequences in those patients
The current management involves hormone replacement therapy and infertility treatment using egg donors
Stem cells are the foundation cells for every organ tissue and cell in the body They are undifferentiated cells that do not yet have specific function Under proper conditions they begin to develop into specialized tissue and organs Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration
This study is an open-label investigation of the efficacy of injection of autologous adipose derived stem cells into the ovarian stroma of patients with premature ovarian failure Totally 10 women with POI will be recruited in this study after the written informed consent Diagnosis will be based mainly on history taking physical examination and laboratory investigations Laboratory investigations will include serum follicle stimulating hormone FSH serum estrogen measurement and serum AMH The typical FSH in POI patients is over 40mIUml post-menopausal range Subjects will be enrolled based on specific inclusionexclusion criteria and will be evaluated at regular post-transplant intervals
The fat derived stem cell will be transplanted by a reproductive gynecologist who does routine ovarian puncture Subjects will be monitored frequently for a total of one year after ADSCs injection For the safety of patients the stem cell will be injected in one ovary only and the other ovary will be spared
Sample of 150-250 ml aspirated from the fat will be processed according to the manufacturers guide and totally 5 million of ADSCs will be injected into the ovaries under guidance of transvaginal sonography Endometrial fractional biopsy will be taken stained with HE stain Participants will be followed up monthly for a period of 6 months by hormonal FSH LH E2 AMH clinical resuming menstruation US folliculometry
This condition occurs in approximately 1 of women and it has significant psychological and physical consequences in those patients
The current management involves hormone replacement therapy and infertility treatment using egg donors
Stem cells are the foundation cells for every organ tissue and cell in the body They are undifferentiated cells that do not yet have specific function Under proper conditions they begin to develop into specialized tissue and organs Fat derived stem cells are mainly mesenchymal stem cells and found to be effective treatment in joint and bone regeneration
This study is an open-label investigation of the efficacy of injection of autologous adipose derived stem cells into the ovarian stroma of patients with premature ovarian failure Totally 10 women with POI will be recruited in this study after the written informed consent Diagnosis will be based mainly on history taking physical examination and laboratory investigations Laboratory investigations will include serum follicle stimulating hormone FSH serum estrogen measurement and serum AMH The typical FSH in POI patients is over 40mIUml post-menopausal range Subjects will be enrolled based on specific inclusionexclusion criteria and will be evaluated at regular post-transplant intervals
The fat derived stem cell will be transplanted by a reproductive gynecologist who does routine ovarian puncture Subjects will be monitored frequently for a total of one year after ADSCs injection For the safety of patients the stem cell will be injected in one ovary only and the other ovary will be spared
Sample of 150-250 ml aspirated from the fat will be processed according to the manufacturers guide and totally 5 million of ADSCs will be injected into the ovaries under guidance of transvaginal sonography Endometrial fractional biopsy will be taken stained with HE stain Participants will be followed up monthly for a period of 6 months by hormonal FSH LH E2 AMH clinical resuming menstruation US folliculometry
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