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

NCT ID: NCT03381807

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2023-09-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TCRA and intrauterine infusion of hAESCs

hAESCs is infused into uterine cavity after TCRA.

Group Type: EXPERIMENTAL

hAESCs

Intervention Type: BIOLOGICAL

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

Interventions

hAESCs

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 1. Previously diagnosed as uterine adhesion, after the operation of TCRA and the postoperatively standardized hormonal replacement therapy(HRT) , recently diagnosed with refractory Asherman's syndrome or endometrial atrophy(EA);
• 2. According to the American Fertility Society(AFS) classification in 1988, patients are diagnosed of AS or EA stageⅢ-Ⅳ confirmed by hysteroscopy;
• 3. Elimination of infertility, recurrent spontaneous abortion or hypomenorrhea caused by other diseases;
• 4. Be willing to maintain an HRT cycle medication throughout the study, unless it is not tolerated;
• 5. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
• 6. Be willing to complete the study and sign the consent form.

Exclusion Criteria

• 1. Patients with severe internal disease;
• 2. The patients are suffering from gynecologic inflammation or active genital tubercle bacillus;
• 3. The patient has other uterine diseases or the abnormal uterine cavity which can't be restored by surgery;
• 4. Infertility due to a man's cause;
• 5. The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy;
• 6. HIV positive
• 7. Active hepatitis B or C infection, syphilis seropositive
• 8. Laboratory routine check index abnormality, such as Hb（hemoglobin）<8.0 g/dL,WBC（white blood cell count）<3,000/ml, platelet counts<75 000/mm3, AST（glutamic oxalacetic transaminase）>ULN（upper limit of normal），ALT（Glutamic pyruvic transaminase）>ULN and so on;
• 9. Patients have any complications that may interfere with safety or efficacy or predict life expectancy of less than 24 months;
• 10. Mental illness in the past 6 months;
• 11. Patients have a history of drug or alcohol abuse or dependence in the past two years;
• 12. Unable or unwilling to give informed consent.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang Liang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Medical College of Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Liang

Role: CONTACT

liangzi1126@126.com

0571-88783738

Liu Yang

Role: CONTACT

liuyangzheda@163.com

0571-88783738

Facility Contacts

YANG LIU

Role: primary

Other Identifiers

2017-080

Identifier Type: -

Identifier Source: org_study_id