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
About this trial
This is an interventional treatment trial for Premature Ovarian Failure
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.
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
NCT ID
NCT03207412
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
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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