Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

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

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.

Study Overview

• Status: Unknown
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Biological: hAECs; Procedure: Minimally invasive implantation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chanyu Zhang; Phone Number: 86-23-63693296; Email: 1317954623@qq.com
• Study Contact Backup: Name: Heng Zou; Phone Number: 86-23-63693296; Email: zouheng3114@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Investigators: Principal Investigator: Chanyu Zhang, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 22, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: POI-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No