Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
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|ClinicalTrials.gov Identifier: NCT04232592|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesion||Biological: Inject a solution of stem cell preparation Biological: Inject stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Stem cell preparation solution injection group
The solution of stem cells preparation will be injected.
Biological: Inject a solution of stem cell preparation
The control group was injected with a solution of stem cell preparation
Experimental: Injected stem cell group
The stem cells will injected.
Biological: Inject stem cells
Three dose groups were designed: low dose group, medium dose group and high dose group.
- Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells [ Time Frame: Within 48 weeks after surgery ]Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.
- Normal recovery rate of endometrial thickness [ Time Frame: 12 months ]Normal recovery rate of endometrial thickness at 1 and 2 months after surgery will be measured (effective rate = endometrium > 6mm after surgery/all participants ×100%).
- recurrence rate of intrauterine adhesions [ Time Frame: 12 months ]Recurrence rate of intrauterine adhesions (defined as patients with recurrence of intrauterine adhesions reviewed by hysteroscopy at 1 month/total patients ×100%) will be measured.
- Intrauterine adhesions score [ Time Frame: 12 months ]Intrauterine adhesions score will be measured according to the American Fertility Society in 1988 diagnostic criteria for intrauterine adhesions.The scores range from 1 to 12. Higher scores mean a worse outcome.
- The endometrial biopsies for CD31 [ Time Frame: 12 months ]Immunohistochemical results of CD31 during the two endometrial biopsies will be measured.
- Menstrual volume change [ Time Frame: 12 months ]Menstrual volume change will be assessed according to menstrual blood loss chart.
- Clinical pregnancy rate [ Time Frame: 12 months ]Clinical pregnancy rate, abortion rate, live birth rate, and sustained pregnancy rate (defined as live pregnancy over 12 weeks) will be assessed.
- The endometrial biopsies for estrogen [ Time Frame: 12 months ]Estrogen receptor levels during the two endometrial biopsies will be measured.
- The endometrial biopsies for Ki67 [ Time Frame: 12 months ]Ki67 expression levels during the two endometrial biopsies will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232592
|Contact: Liu Wang, Doctorfirstname.lastname@example.org|
|Contact: Jie Hao, Doctoremail@example.com|
|Principal Investigator:||Qi Zhou, Doctor||Institute of zoology, Chinese Academy of Sciences|