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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03381807
Other study ID # 2017-080
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 16, 2020
Est. completion date September 1, 2023

Study information

Verified date October 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wang Liang
Phone 0571-88783738
Email liangzi1126@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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 stage?-? 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
hAESCs
5*10^7 hAESCs is infused into uterine cavity with TCRA on Day0, Day7 and after the first menstruation

Locations

Country Name City State
China Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at the 1, 3,6 and 9 months after surgery
Primary 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. at the 1, 3,6 and 9 months after surgery
Secondary pregnancy rate Ultrasound reveals that the fetus had a heart activity 24 months
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