Human Amniotic Epithelial Cells for Asherman's Syndrome

Chongqing Medical University

Status and phase: Unknown; Phase 1

Conditions: Asherman's Syndrome

Treatments: Biological: biological amnion; Biological: hAECs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03223454

2017-116

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 5 patient groups, including a placebo group

biological amnion loaded with hAECs

Experimental group

Description:

Biological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA.

Treatment:

Biological: hAECs

biological amnion

Placebo Comparator group

Description:

Biological amnion is placed into uterine cavity immediately after TCRA.

Treatment:

Biological: biological amnion

intravenous infusion of hAECs

Experimental group

Description:

intravenous infusion of 100 million hAECs immediately after TCRA

Treatment:

Biological: hAECs

intrauterine infusion of hAECs

Experimental group

Description:

100 million hAECs is infused into uterine cavity immediately after TCRA.

Treatment:

Biological: hAECs

hydrogel loaded with hAECs

Experimental group

Description:

Hydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA.

Treatment:

Biological: hAECs