Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03207412
• Other study ID #: POI-2017
• Status: Not yet recruiting
• Phase: N/A
• First received: June 30, 2017
• Last updated: June 30, 2017
• Start date: December 22, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2017
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Chanyu Zhang
• Phone: 86-23-63693296
• Email: 1317954623[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• hAECs
human amniotic epithelial cells

Procedure:
• Minimally invasive implantation
Minimally invasive implantation with ultrasound guidance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of follicle stimulating hormone(FSH)	Serum FSH level is evaluated once a month after treatment.	1 year
Primary	antral follicle count (AFC)	the number of primordial egg follicles within the ovary per menstrual cycle	1 year
Secondary	Menstrual situation	Changes of menstrual cycle and menstrual period before and after treatment.	1 year
Secondary	Luteinizing Hormone(LH)	serum level of LH	1 year
Secondary	estrogen 2(E2)	serum level of E2	1 year
Secondary	Anti Mullerian Hormone(AMH)	serum level of AMH	1 year
Secondary	Ovarian volume	The ovarian volume is recorded by transvaginal ultrasound scan.	1 year