NCT03381807

Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
BIOLOGICAL	hAESCs	5\*10\^7 hAESCs is infused into uterine cavity with TCRA on Day0, Day7 and after the first menstruation

Timeline

• Start date: 2020-09-16
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2017-12-22
• Last updated: 2020-10-28

Locations

1 site across 1 country: China