Status:
UNKNOWN
Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Conditions:
Intrauterine Adhesion
Eligibility:
FEMALE
20-45 years
Phase:
EARLY_PHASE1
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03381807
Start Date
September 16 2020
End Date
September 1 2023
Last Update
October 28 2020
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009