Premature Ovarian Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALhAECs
human amniotic epithelial cells
PROCEDUREMinimally invasive implantation
Minimally invasive implantation with ultrasound guidance
Sponsors
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of POI, excluding genetic disease caused by patients; POI diagnostic criteria: Patients that \<40 years of age, oligomenorrhea for 4 months,FSH\> 25 IU/L. 2. Have fertility requirements; 3. Agree to sign the designed consent for the study.
Exclusion criteria
1. Breast cancer, ovarian cancer and other cancer/tumor; 2. Contraindications for pregnancy; 3. Coagulation disorder and other abnormal physical conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of follicle stimulating hormone(FSH) | 1 year | Serum FSH level is evaluated once a month after treatment. |
| antral follicle count (AFC) | 1 year | the number of primordial egg follicles within the ovary per menstrual cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| estrogen 2(E2) | 1 year | serum level of E2 |
| Menstrual situation | 1 year | Changes of menstrual cycle and menstrual period before and after treatment. |
| Ovarian volume | 1 year | The ovarian volume is recorded by transvaginal ultrasound scan. |
| Anti Mullerian Hormone(AMH) | 1 year | serum level of AMH |
| Luteinizing Hormone(LH) | 1 year | serum level of LH |
Contacts
Primary ContactChanyu Zhang
Backup ContactHeng Zou
Outcome results
None listed