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Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

Primary Purpose

Premature Ovarian Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hAECs
Minimally invasive implantation
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Failure

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Minimally invasive implantation

    Intravenous infusion

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Menstrual situation
    Changes of menstrual cycle and menstrual period before and after treatment.
    Luteinizing Hormone(LH)
    serum level of LH
    estrogen 2(E2)
    serum level of E2
    Anti Mullerian Hormone(AMH)
    serum level of AMH
    Ovarian volume
    The ovarian volume is recorded by transvaginal ultrasound scan.

    Full Information

    First Posted
    June 30, 2017
    Last Updated
    June 30, 2017
    Sponsor
    The Second Affiliated Hospital of Chongqing Medical University
    Collaborators
    Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03207412
    Brief Title
    Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency
    Official Title
    Clinical Study of Minimally Invasive Implantation of Human Amniotic Epithelial Cells in the Treatment of Premature Ovarian Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 22, 2017 (Anticipated)
    Primary Completion Date
    July 1, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Second Affiliated Hospital of Chongqing Medical University
    Collaborators
    Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ovarian Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimally invasive implantation
    Arm Type
    Experimental
    Arm Description
    Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture.
    Arm Title
    Intravenous infusion
    Arm Type
    Experimental
    Arm Description
    100 million hAECs is administered by intravenous infusion every 30 days, for 3 times.
    Intervention Type
    Biological
    Intervention Name(s)
    hAECs
    Intervention Description
    human amniotic epithelial cells
    Intervention Type
    Procedure
    Intervention Name(s)
    Minimally invasive implantation
    Intervention Description
    Minimally invasive implantation with ultrasound guidance
    Primary Outcome Measure Information:
    Title
    Changes of follicle stimulating hormone(FSH)
    Description
    Serum FSH level is evaluated once a month after treatment.
    Time Frame
    1 year
    Title
    antral follicle count (AFC)
    Description
    the number of primordial egg follicles within the ovary per menstrual cycle
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Menstrual situation
    Description
    Changes of menstrual cycle and menstrual period before and after treatment.
    Time Frame
    1 year
    Title
    Luteinizing Hormone(LH)
    Description
    serum level of LH
    Time Frame
    1 year
    Title
    estrogen 2(E2)
    Description
    serum level of E2
    Time Frame
    1 year
    Title
    Anti Mullerian Hormone(AMH)
    Description
    serum level of AMH
    Time Frame
    1 year
    Title
    Ovarian volume
    Description
    The ovarian volume is recorded by transvaginal ultrasound scan.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Have fertility requirements; Agree to sign the designed consent for the study. Exclusion Criteria: Breast cancer, ovarian cancer and other cancer/tumor; Contraindications for pregnancy; Coagulation disorder and other abnormal physical conditions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chanyu Zhang
    Phone
    86-23-63693296
    Email
    1317954623@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heng Zou
    Phone
    86-23-63693296
    Email
    zouheng3114@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chanyu Zhang
    Organizational Affiliation
    The Second Affiliated Hospital of Chongqing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency

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