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Human Amniotic Epithelial Cells for Asherman's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223454
Recruitment Status : Not yet recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
The Second Affiliated Hospital of Chongqing Medical University

Study Description
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Brief Summary:
This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Condition or disease Intervention/treatment Phase
Asherman's Syndrome Biological: hAECs Biological: biological amnion Phase 1

Detailed Description:

Asherman's syndrome is a 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 cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice were significantly improved after intrauterine therapy with amniotic epithelial cells. To further explore the role of hAECs in Asherman's syndrome patients, this project plans to evaluate the safety of hAECs provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd., and find an effective treatment protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: biological amnion loaded with hAECs
Biological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA.
 Biological: hAECs
hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
Placebo Comparator: biological amnion
Biological amnion is placed into uterine cavity immediately after TCRA.
 Biological: biological amnion
Biological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
Experimental: intravenous infusion of hAECs
intravenous infusion of 100 million hAECs immediately after TCRA
 Biological: hAECs
hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
Experimental: intrauterine infusion of hAECs
100 million hAECs is infused into uterine cavity immediately after TCRA.
 Biological: hAECs
hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
Experimental: hydrogel loaded with hAECs
Hydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA.
 Biological: hAECs
hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Menstrual blood volume [ Time Frame: at 3 months ]
    Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days, which will be compared with pre-operation.


Secondary Outcome Measures :
  1. Endometrial thickness [ Time Frame: at 3 months ]
    Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.

  2. Uterine volume [ Time Frame: at 3 months ]
    Measure the uterine volume during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.

  3. Ongoing pregnancy rate [ Time Frame: up to 24 months ]
    A ongoing pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart beat and the size of the fetus is in consistent with the gestational week.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
  • 2. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
  • 3. Having a clear desire to fertility;
  • 4. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
  • 5. Serum β-hCG is negative;
  • 6. Be willing to complete the study and sign the consent form.

Exclusion Criteria:

  • 1. Having a history of malignant tumor;
  • 2. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
  • 3. Hysteroscopic adhesiolysis more than 3 times in the past;
  • 4. Absence of peripheral vein access.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223454


Contacts
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Contact: Lina Hu 86-23-63693707 cqhulina@126.com
Contact: Chanyu Zhang 86-23-63693296 1317954623@qq.com

Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
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Study Chair: Lina Hu The Second Affiliated Hospital of Chongqing Medical University
Principal Investigator: Chanyu Zhang The Second Affiliated Hospital of Chongqing Medical University
Principal Investigator: Fan He The Second Affiliated Hospital of Chongqing Medical University
Principal Investigator: Jianguo Hu The Second Affiliated Hospital of Chongqing Medical University
Principal Investigator: Heng Zou The Second Affiliated Hospital of Chongqing Medical University
Principal Investigator: Huijia Chen The Second Affiliated Hospital of Chongqing Medical University
More Information
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Publications:

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Responsible Party: The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03223454    
Other Study ID Numbers: 2017-116
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gynatresia
Syndrome
Disease
Pathologic Processes