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Human Amniotic Epithelial Cell in Treatment of Refractory Severe Intrauterine Adhesion

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ClinicalTrials.gov Identifier: NCT03381807
Recruitment Status : Not yet recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
This project will investigate the safety and effectiveness of human amniotic epithelial cells for treatment of severe refractory Asherman's syndrome.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Biological: hAECs Early Phase 1

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 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 was significantly improved after intrauterine therapy with amniotic epithelial cells. To further explore the role of hAECs in Asherman's syndrome patients, this project will evaluate the safety of hAECs and find an effective treatment protocols.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Amniotic Epithelial Cell in Treatment of Refractory Severe Intrauterine Adhesion
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: TCRA and intrauterine infusion of hAECs
100 million hAECs is infused into uterine cavity after TCRA.
Biological: hAECs
100 million hAECs is infused into uterine cavity after TCRA.




Primary Outcome Measures :
  1. changes of Endometrial thickness [ Time Frame: at the 1, 3,6 and 9 months after surgery ]
    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.

  2. changes of Menstrual blood volume [ Time Frame: at the 1, 3,6 and 9 months after surgery ]
    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 :
  1. pregnancy rate [ Time Frame: 24 months ]
    Ultrasound reveals that the fetus had a heart activity



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.Women are older than 45 or no demand for reproduction;
  • 2.Diagnosis and classification of patients with mild, moderate uterine adhesion;
  • 3.Patients with severe internal disease;
  • 4.The patients are suffering from gynecologic inflammation or active genital tubercle bacillus;
  • 5.The patient has other uterine diseases, such as uterine fibroids, uterine adenomyomas, or the abnormal uterine cavity which can't be restored by surgery;
  • 6.Infertility due to a man's cause;
  • 7.The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy;
  • 8.Laboratory routine check index abnormality,such as Hb(hemoglobin)<8.0 g/dL,WBC(white blood cell count)<3,000,000/mm3,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.Patients have a history of drug or alcohol abuse or dependence in the past two years;
  • 11.Unable or unwilling to give informed consent.

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): NCT03381807


Contacts
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Contact: Wang Liang 0571-88783738 liangzi1126@126.com
Contact: Liu Yang 0571-88783738 liuyangzheda@163.com

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
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Principal Investigator: Wang Liang The Second Affiliated Hospital of Medical College of Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03381807     History of Changes
Other Study ID Numbers: 2017-080
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: November 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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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes