Human Amniotic Epithelial Cells for Asherman's Syndrome
Safety and Therapeutic Effect of Human Amniotic Epithelial Cells in Severe Refractory Asherman's Syndrome
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2017
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJuly 21, 2017
July 1, 2017
1.9 years
July 13, 2017
July 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Endometrial thickness
at 3 months
Uterine volume
at 3 months
Ongoing pregnancy rate
up to 24 months
Study Arms (5)
biological amnion loaded with hAECs
EXPERIMENTALBiological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA.
biological amnion
PLACEBO COMPARATORBiological amnion is placed into uterine cavity immediately after TCRA.
intravenous infusion of hAECs
EXPERIMENTALintravenous infusion of 100 million hAECs immediately after TCRA
intrauterine infusion of hAECs
EXPERIMENTAL100 million hAECs is infused into uterine cavity immediately after TCRA.
hydrogel loaded with hAECs
EXPERIMENTALHydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- \. Hysteroscopy examination confirms intrauterine adhesions, II -III according to the American Fertility Society (AFS) classification of uterine adhesions;
- \. Regular Menstrual cycles and menstruation is normal before abortion or curettage;
- \. Having a clear desire to fertility;
- \. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
- \. Serum β-hCG is negative;
- \. Be willing to complete the study and sign the consent form.
You may not qualify if:
- \. Having a history of malignant tumor;
- \. Having other uterine diseases, such as, uterine fibroids, adenomyosis and uterine malformations;
- \. Hysteroscopic adhesiolysis more than 3 times in the past;
- \. Absence of peripheral vein access.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 18406834BACKGROUNDIlancheran 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.
PMID: 18995896BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lina Hu
The Second Affiliated Hospital of Chongqing Medical University
- PRINCIPAL INVESTIGATOR
Chanyu Zhang
The Second Affiliated Hospital of Chongqing Medical University
- PRINCIPAL INVESTIGATOR
Fan He
The Second Affiliated Hospital of Chongqing Medical University
- PRINCIPAL INVESTIGATOR
Jianguo Hu
The Second Affiliated Hospital of Chongqing Medical University
- PRINCIPAL INVESTIGATOR
Heng Zou
The Second Affiliated Hospital of Chongqing Medical University
- PRINCIPAL INVESTIGATOR
Huijia Chen
The Second Affiliated Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 21, 2017
Study Start
October 1, 2017
Primary Completion
September 1, 2019
Study Completion
March 1, 2021
Last Updated
July 21, 2017
Record last verified: 2017-07