Human Amniotic Epithelial Cells for Asherman's Syndrome

Asherman's Syndrome Clinical Trial

Official title:

Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03223454
• Other study ID #: 2017—116
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 13, 2017
• Last updated: July 19, 2017
• Start date: October 2017
• Est. completion date: March 2021

Study information

• Verified date: July 2017
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Lina Hu
• Phone: 86-23-63693707
• Email: cqhulina[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Asherman's Syndrome
• Syndrome

Intervention

Biological:
• hAECs
hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
• biological amnion
Biological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual blood volume	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.	at 3 months
Secondary	Endometrial thickness	Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.	at 3 months
Secondary	Uterine volume	Measure the uterine volume during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.	at 3 months
Secondary	Ongoing pregnancy rate	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.	up to 24 months