Clinical trial NCT03223454: Human Amniotic Epithelial Cells for Asherman's Syndrome
Official title: Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Asherman's Syndrome
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2017-07-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Menstrual blood volume
timeFrame: at 3 months
Secondary outcomes:
measure: Endometrial thickness
timeFrame: at 3 months
measure: Uterine volume
timeFrame: at 3 months
measure: Ongoing pregnancy rate
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Lina Hu
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Chanyu Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Fan He
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Jianguo Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Heng Zou
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Huijia Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
citation: Ilancheran S, Moodley Y, Manuelpillai U. Human fetal membranes: a source of stem cells for tissue regeneration and repair? Placenta. 2009 Jan;30(1):2-10. doi: 10.1016/j.placenta.2008.09.009. Epub 2008 Nov 7.