search
Back to results

Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion

Primary Purpose

Intrauterine Adhesion

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
hAESCs
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Adhesion

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Previously diagnosed as uterine adhesion, after the operation of TCRA and the postoperatively standardized hormonal replacement therapy(HRT) , recently diagnosed with refractory Asherman's syndrome or endometrial atrophy(EA);
  • 2. According to the American Fertility Society(AFS) classification in 1988, patients are diagnosed of AS or EA stageⅢ-Ⅳ confirmed by hysteroscopy;
  • 3. Elimination of infertility, recurrent spontaneous abortion or hypomenorrhea caused by other diseases;
  • 4. Be willing to maintain an HRT cycle medication throughout the study, unless it is not tolerated;
  • 5. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
  • 6. Be willing to complete the study and sign the consent form.

Exclusion Criteria:

  • 1. Patients with severe internal disease;
  • 2. The patients are suffering from gynecologic inflammation or active genital tubercle bacillus;
  • 3. The patient has other uterine diseases or the abnormal uterine cavity which can't be restored by surgery;
  • 4. Infertility due to a man's cause;
  • 5. The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy;
  • 6. HIV positive
  • 7. Active hepatitis B or C infection, syphilis seropositive
  • 8. Laboratory routine check index abnormality, such as Hb（hemoglobin）<8.0 g/dL,WBC（white blood cell count）<3,000/ml, platelet counts<75 000/mm3, AST（glutamic oxalacetic transaminase）>ULN（upper limit of normal），ALT（Glutamic pyruvic transaminase）>ULN and so on;
  • 9. Patients have any complications that may interfere with safety or efficacy or predict life expectancy of less than 24 months;
  • 10. Mental illness in the past 6 months;
  • 11. Patients have a history of drug or alcohol abuse or dependence in the past two years;
  • 12. Unable or unwilling to give informed consent.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TCRA and intrauterine infusion of hAESCs

Arm Description

hAESCs is infused into uterine cavity after TCRA.

Outcomes

Primary Outcome Measures

changes of Endometrial thickness
Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 1,3,6 and 9 months after surgery, comparing with pre-operation.
changes of Menstrual blood volume
Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days to menstruation at 1, 3, 6, 9 months after surgery, which will be compared with pre-operation.

Secondary Outcome Measures

pregnancy rate
Ultrasound reveals that the fetus had a heart activity

Full Information

First Posted
November 27, 2017
Last Updated
October 25, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
search

1. Study Identification

Unique Protocol Identification Number
NCT03381807
Brief Title
Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion
Official Title
Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang 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
No

5. Study Description

Brief Summary
This project will investigate the safety and effectiveness of human amniotic epithelial stem cells for treatment of severe refractory Asherman's syndrome.
Detailed Description
Asherman's syndrome is an gynecological disorder caused by the destruction of the endometrium due to repeated or aggressive curettages and/or endometritis. As a result, there is a loss of functional endometrium in multiple areas and the uterine cavity is obliterated by intrauterine adhesions, which results in amenorrhea, hypomenorrhea, infertility and recurrent pregnancy loss. Transcervical resection of adhesion (TCRA) is the main treatment for Asherman's syndrome; so far the effect is usually poor in moderate to severe refractory cases. Human amniotic epithelial stem cells (hAESCs) are derived from human amniotic epithelium. hAESCs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice was significantly improved after intrauterine therapy with hAESCs. To further explore the role of hAESCs in Asherman's syndrome patients, this project will evaluate the safety of hAESCs and find an effective treatment protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TCRA and intrauterine infusion of hAESCs
Arm Type
Experimental
Arm Description
hAESCs is infused into uterine cavity after TCRA.
Intervention Type
Biological
Intervention Name(s)
hAESCs
Intervention Description
5*10^7 hAESCs is infused into uterine cavity with TCRA on Day0, Day7 and after the first menstruation
Primary Outcome Measure Information:
Title
changes of Endometrial thickness
Description
Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 1,3,6 and 9 months after surgery, comparing with pre-operation.
Time Frame
at the 1, 3，6 and 9 months after surgery
Title
changes of Menstrual blood volume
Description
Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days to menstruation at 1, 3, 6, 9 months after surgery, which will be compared with pre-operation.
Time Frame
at the 1, 3，6 and 9 months after surgery
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
Ultrasound reveals that the fetus had a heart activity
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Previously diagnosed as uterine adhesion, after the operation of TCRA and the postoperatively standardized hormonal replacement therapy(HRT) , recently diagnosed with refractory Asherman's syndrome or endometrial atrophy(EA); 2. According to the American Fertility Society(AFS) classification in 1988, patients are diagnosed of AS or EA stageⅢ-Ⅳ confirmed by hysteroscopy; 3. Elimination of infertility, recurrent spontaneous abortion or hypomenorrhea caused by other diseases; 4. Be willing to maintain an HRT cycle medication throughout the study, unless it is not tolerated; 5. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology; 6. Be willing to complete the study and sign the consent form. Exclusion Criteria: 1. Patients with severe internal disease; 2. The patients are suffering from gynecologic inflammation or active genital tubercle bacillus; 3. The patient has other uterine diseases or the abnormal uterine cavity which can't be restored by surgery; 4. Infertility due to a man's cause; 5. The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy; 6. HIV positive 7. Active hepatitis B or C infection, syphilis seropositive 8. Laboratory routine check index abnormality, such as Hb（hemoglobin）<8.0 g/dL,WBC（white blood cell count）<3,000/ml, platelet counts<75 000/mm3, AST（glutamic oxalacetic transaminase）>ULN（upper limit of normal），ALT（Glutamic pyruvic transaminase）>ULN and so on; 9. Patients have any complications that may interfere with safety or efficacy or predict life expectancy of less than 24 months; 10. Mental illness in the past 6 months; 11. Patients have a history of drug or alcohol abuse or dependence in the past two years; 12. Unable or unwilling to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Liang
Phone
0571-88783738
Email
liangzi1126@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Yang
Phone
0571-88783738
Email
liuyangzheda@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Liang
Organizational Affiliation
The Second Affiliated Hospital of Medical College of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YANG LIU

12. IPD Sharing Statement

Learn more about this trial

Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion

We'll reach out to this number within 24 hrs