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Human Amniotic Epithelial Cells for Asherman's Syndrome

C

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;
    1. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
    1. Having a clear desire to fertility;
    1. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
    1. Serum β-hCG is negative;
    1. Be willing to complete the study and sign the consent form.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

0

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Central trial contact

Lina Hu; Chanyu Zhang

Data sourced from clinicaltrials.gov

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