Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 主要终点
- Menstrual blood volume
研究概览
简要总结
This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
- •Regular Menstrual cycles and menstruation is normal before abortion or curettage;
- •Having a clear desire to fertility;
- •Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
- •Serum β-hCG is negative;
- •Be willing to complete the study and sign the consent form.
排除标准
- •Having a history of malignant tumor;
- •Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
- •Hysteroscopic adhesiolysis more than 3 times in the past;
- •Absence of peripheral vein access.
研究组 & 干预措施
biological amnion loaded with hAECs
Biological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA.
干预措施: hAECs (Biological)
intrauterine infusion of hAECs
100 million hAECs is infused into uterine cavity immediately after TCRA.
干预措施: hAECs (Biological)
biological amnion
Biological amnion is placed into uterine cavity immediately after TCRA.
干预措施: biological amnion (Biological)
intravenous infusion of hAECs
intravenous infusion of 100 million hAECs immediately after TCRA
干预措施: hAECs (Biological)
hydrogel loaded with hAECs
Hydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA.
干预措施: hAECs (Biological)
结局指标
主要结局
Menstrual blood volume
时间窗: 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.
次要结局
- Ongoing pregnancy rate(up to 24 months)
- Endometrial thickness(at 3 months)
- Uterine volume(at 3 months)