Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Chongqing Medical University

Status: Unknown

Conditions: Premature Ovarian Failure

Treatments: Biological: hAECs; Procedure: Minimally invasive implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03207412

POI-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Minimally invasive implantation

Experimental group

Description:

Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture.

Treatment:

Biological: hAECs

Procedure: Minimally invasive implantation

Intravenous infusion

Experimental group

Description:

100 million hAECs is administered by intravenous infusion every 30 days, for 3 times.

Treatment:

Biological: hAECs