This project will investigate the safety and effectiveness of human amniotic epithelial stem cells for treatment of severe refractory Asherman's syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
5\*10\^7 hAESCs is infused into uterine cavity with TCRA on Day0, Day7 and after the first menstruation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGchanges 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.
Time frame: at the 1, 3,6 and 9 months after surgery
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.
Time frame: at the 1, 3,6 and 9 months after surgery
pregnancy rate
Ultrasound reveals that the fetus had a heart activity
Time frame: 24 months
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