NCT06132542

Autologous ADMSC Transplantation in Patients With POI

Autologous Adipose Derived Mesenchymal Stromal Cell Transplantation in Patients With Idiopathic or Drug Induced Premature Ovarian Failure

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Mongolian National University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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 40mIU/ml (post-menopausal range). Subjects will be enrolled based on specific inclusion/exclusion 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 H\&E stain. Participants will be followed up monthly for a period of 6 months by hormonal (FSH, LH, E2, AMH), clinical (resuming menstruation), US (folliculometry).

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
BIOLOGICAL	stem cell therapy	The fat derived stem cell will be transplanted by a reproductive gynecologist who does routine ovarian puncture.

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-10-15
• Completion: 2024-12-15
• First posted: 2023-11-15
• Last updated: 2023-11-15

Locations

1 site across 1 country: Mongolia