Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Not Applicable

• Conditions: Premature Ovarian Failure

• Registration Number: NCT03207412
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Last Update Submitted: 2017-06-30
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02
• Study Start: 2017-12-22
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anti Mullerian Hormone(AMH)	1 year	serum level of AMH
estrogen 2(E2)	1 year	serum level of E2
Menstrual situation	1 year	Changes of menstrual cycle and menstrual period before and after treatment.
Luteinizing Hormone(LH)	1 year	serum level of LH
Ovarian volume	1 year	The ovarian volume is recorded by transvaginal ultrasound scan.