Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study of Minimally Invasive Implantation of Human Amniotic Epithelial Cells in the Treatment of Premature Ovarian Insufficiency

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: hAECs
* Procedure: Minimally invasive implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Have fertility requirements; Agree to sign the designed consent for the study. Exclusion Criteria: Breast cancer, ovarian cancer and other cancer/tumor; Contraindications for pregnancy; Coagulation disorder and other abnormal physical conditions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive implantation<br>Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture. | Biological: hAECs<br>* human amniotic epithelial cells<br>Procedure: Minimally invasive implantation<br>* Minimally invasive implantation with ultrasound guidance<br>|
| Experimental: Intravenous infusion<br>100 million hAECs is administered by intravenous infusion every 30 days, for 3 times. | Biological: hAECs<br>* human amniotic epithelial cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |