NCT04232592Unknown1 期
Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
Qi Zhou0 个研究点目标入组 32 人开始时间: 2020年1月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 主要终点
- Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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., hematemesis, black, serious or recurrent nasal bleeding, coughing up blood, obvious hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected of vascular malformation such as aneurysm by researchers determine influence cell implant operation;
- •Alcohol or drug addiction;
- •Participated in other interventional clinical trials within 90 days before the informed consent was signed or before the cell transplantation;
- •Had used glucocorticoids or immunosuppressive drugs within 12 weeks before signing the informed consent;
- •Had used antipsychotic drugs, such as antidepressants and anti-manic drugs, within 12 weeks before signing the informed consent;
- •Severe heart failure within 24 weeks before the informed consent;
- •Glomerular filtration rate (eGFR) <90ml/min;
- •ALT>3 times normal upper limit;
- •Concomitant with other serious systemic diseases, such as pulmonary heart disease, severe chronic obstructive pulmonary disease (COPD), etc;
- •Patients with severe clinical infection should receive antibiotics within 1 week before signing the informed consent;
- •Active infectious diseases, including but not limited to positive human immunodeficiency virus and syphilis antibody;
- •The researchers considered poor compliance;
- •Other conditions not suitable for participation in this clinical trial.
结局指标
主要结局
Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells
时间窗: Within 48 weeks after surgery
Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.
次要结局
- Menstrual volume change(12 months)
- The endometrial biopsies for Ki67(12 months)
- Normal recovery rate of endometrial thickness(12 months)
- Intrauterine adhesions score(12 months)
- The endometrial biopsies for CD31(12 months)
- The endometrial biopsies for estrogen(12 months)
- recurrence rate of intrauterine adhesions(12 months)
- Clinical pregnancy rate(12 months)
研究者
Qi Zhou
Director of Institute of zoology, chinese academy of sciences, and vice president of medical school， University of chinese academy of sciences
Chinese Academy of Sciences
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