To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
In this study, a single-center, controlled, open-label design was used for a dose escalation study.To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
The control group was injected with a solution of stem cell preparation
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
Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.
Time frame: Within 48 weeks after surgery
Normal recovery rate of endometrial thickness
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%).
Time frame: 12 months
recurrence rate of intrauterine adhesions
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.
Time frame: 12 months
Intrauterine adhesions score
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.
Time frame: 12 months
The endometrial biopsies for CD31
Immunohistochemical results of CD31 during the two endometrial biopsies will be measured.
Time frame: 12 months
Menstrual volume change
Menstrual volume change will be assessed according to menstrual blood loss chart.
Time frame: 12 months
Clinical pregnancy rate
Clinical pregnancy rate, abortion rate, live birth rate, and sustained pregnancy rate (defined as live pregnancy over 12 weeks) will be assessed.
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Time frame: 12 months
The endometrial biopsies for estrogen
Estrogen receptor levels during the two endometrial biopsies will be measured.
Time frame: 12 months
The endometrial biopsies for Ki67
Ki67 expression levels during the two endometrial biopsies will be measured.
Time frame: 12 months