Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Not Applicable

• Conditions: Premature Ovarian Failure
• Interventions: Biological: hAECs; Procedure: Minimally invasive implantation

• 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

Arm && Interventions

Group	Intervention	Description
Minimally invasive implantation	hAECs	Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture.
Intravenous infusion	hAECs	100 million hAECs is administered by intravenous infusion every 30 days, for 3 times.
Minimally invasive implantation	Minimally invasive implantation	Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture.

Primary Outcome Measures

Name	Time	Method
antral follicle count (AFC)	1 year	the number of primordial egg follicles within the ovary per menstrual cycle
Changes of follicle stimulating hormone(FSH)	1 year	Serum FSH level is evaluated once a month after treatment.

Secondary Outcome Measures

Name	Time	Method
estrogen 2(E2)	1 year	serum level of E2
Luteinizing Hormone(LH)	1 year	serum level of LH
Anti Mullerian Hormone(AMH)	1 year	serum level of AMH
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.