Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

NCT ID: NCT03207412

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Premature Ovarian Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Minimally invasive implantation

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

Group Type EXPERIMENTAL

hAECs

Intervention Type BIOLOGICAL

human amniotic epithelial cells

Minimally invasive implantation

Intervention Type PROCEDURE

Minimally invasive implantation with ultrasound guidance

Intravenous infusion

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

Group Type EXPERIMENTAL

hAECs

Intervention Type BIOLOGICAL

human amniotic epithelial cells

Interventions

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hAECs

human amniotic epithelial cells

Intervention Type BIOLOGICAL

Minimally invasive implantation

Minimally invasive implantation with ultrasound guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chanyu Zhang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Central Contacts

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Chanyu Zhang

Role: CONTACT

86-23-63693296

Heng Zou

Role: CONTACT

86-23-63693296

Other Identifiers

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POI-2017

Identifier Type: -

Identifier Source: org_study_id

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