Human Amniotic Epithelial Cells for Asherman's Syndrome

Phase 1

• Conditions: Asherman's Syndrome
• Interventions: Biological: hAECs; Biological: biological amnion

• Registration Number: NCT03223454
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Detailed Description

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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-19
• Last Update Submitted: 2017-07-19
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Study Start: 2017-10
• Primary Completion: 2019-09
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 1. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
• 2. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
• 3. Having a clear desire to fertility;
• 4. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
• 5. Serum β-hCG is negative;
• 6. Be willing to complete the study and sign the consent form.

Exclusion Criteria

• 1. Having a history of malignant tumor;
• 2. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
• 3. Hysteroscopic adhesiolysis more than 3 times in the past;
• 4. Absence of peripheral vein access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biological amnion loaded with hAECs	hAECs	Biological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA.
intrauterine infusion of hAECs	hAECs	100 million hAECs is infused into uterine cavity immediately after TCRA.
biological amnion	biological amnion	Biological amnion is placed into uterine cavity immediately after TCRA.
hydrogel loaded with hAECs	hAECs	Hydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA.
intravenous infusion of hAECs	hAECs	intravenous infusion of 100 million hAECs immediately after TCRA

Primary Outcome Measures

Name	Time	Method
Menstrual blood volume	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.

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	up to 24 months	A ongoing pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart beat and the size of the fetus is in consistent with the gestational week.
Endometrial thickness	at 3 months	Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.
Uterine volume	at 3 months	Measure the uterine volume during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.