Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of … (NCT04232592) | Clinical Trial Compass
UnknownPhase 1
Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
32 participantsStarted 2020-01
Plain-language summary
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.
Who can participate
Age range18 Years – 38 Years
SexFEMALE
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Criteria:
Inclusion Criteria:
* 18 ≤ age ≤38, female;
* According to the 1988 American Fertility Society (AFS) diagnostic criteria, patients with uterine adhesions diagnosed with full civil capacity and with a score of ≥5 were enrolled in the study;
* The patient had one or more of the following clinical symptoms: reduced menstruation or amenorrhea, periodic abdominal pain, secondary infertility, recurrent abortion, premature delivery and other adverse pregnancy outcomes;
* The uterus was smaller than 8 weeks gestation and the uterine cavity depth was less than 12 cm;
* The second to fifth day of menstruation FSH \<10mIU/mL, AMH \>1.2ng/mL, AFC\>6;
* Understand and sign informed consent voluntarily.
Exclusion Criteria:
* Patients with acute pelvic inflammation or endometriosis;
* Having or having a history of malignancy;
* Thrombus, lupus erythematosus and other hormone use contraindications; Allergic to albumin products;
* Patients with uterine malformation, adenomyosis, submucosal uterine fibroids,and uterine fibroids of any site \>5cm;
* Patients who were using anticoagulants or who had not recovered normal platelet function 10 days after discontinuation of antiplatelet drugs;
* Previous history of abnormal coagulation function or abnormality before cell transplantation;
* Always has a history of abnormal bleeding (such as abnormal bleeding during tooth extraction), or their immediate family members have hemorrhagic disease,such as hemophilia, bleeding symptoms (e.g., …
What they're measuring
1
Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells