Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive implantation | Experimental | Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture. |
|
| Intravenous infusion | Experimental | 100 million hAECs is administered by intravenous infusion every 30 days, for 3 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hAECs | Biological | human amniotic epithelial cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of follicle stimulating hormone(FSH) | Serum FSH level is evaluated once a month after treatment. | 1 year |
| antral follicle count (AFC) | the number of primordial egg follicles within the ovary per menstrual cycle | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual situation | Changes of menstrual cycle and menstrual period before and after treatment. | 1 year |
| Luteinizing Hormone(LH) | serum level of LH |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chanyu Zhang | Contact | 86-23-63693296 | 1317954623@qq.com | |
| Heng Zou | Contact | 86-23-63693296 | zouheng3114@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chanyu Zhang | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Minimally invasive implantation | Procedure | Minimally invasive implantation with ultrasound guidance |
|
| 1 year |
| estrogen 2(E2) | serum level of E2 | 1 year |
| Anti Mullerian Hormone(AMH) | serum level of AMH | 1 year |
| Ovarian volume | The ovarian volume is recorded by transvaginal ultrasound scan. | 1 year |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |