This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.
Premature ovarian insufficiency (POI) refers to women before the 40 years of age who suffer clinical manifestations of ovarian recession. Now, there is no exact and effective treatment to restore ovarian function. Human amniotic Epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics of embryonic stem cells, as well as a strong differentiation potential and plasticity. Experiments show that the fertility of mice is significantly improved after amniotic epithelial cells implantation. In order to further study the role of hAECs in POI treatment, this project will conduct minimally invasive implantation with hAECs in 20 cases of POI patients, and evaluate the changes of ovarian function and the safety of hAECs implantation. hAECs is prepared by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
human amniotic epithelial cells
Minimally invasive implantation with ultrasound guidance
Changes of follicle stimulating hormone(FSH)
Serum FSH level is evaluated once a month after treatment.
Time frame: 1 year
antral follicle count (AFC)
the number of primordial egg follicles within the ovary per menstrual cycle
Time frame: 1 year
Menstrual situation
Changes of menstrual cycle and menstrual period before and after treatment.
Time frame: 1 year
Luteinizing Hormone(LH)
serum level of LH
Time frame: 1 year
estrogen 2(E2)
serum level of E2
Time frame: 1 year
Anti Mullerian Hormone(AMH)
serum level of AMH
Time frame: 1 year
Ovarian volume
The ovarian volume is recorded by transvaginal ultrasound scan.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.