A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cell (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intrauterine adhesion patients efficacy evaluation
研究概览
简要总结
The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in Healing Poor After Uterus Injury disease
详细描述
This is a random, open label, and self-control experiment. 10 patients are selected and sign consent forms, then divided into one group. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of healing Poor after Uterus Injury (Menstrual conditions, Visual analogue scale, pregnancies).
All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 3 and 6 month after treatment, and do efficacy evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, with BMI 18-24 kg/m^2
- •Meet the clinical standard of Healing Poor After Uterus Injury
- •Non smoker
- •Do not accept stem cells treatment in 6 months
- •Participants or their family members sign the consent form of this study
排除标准
- •Pregnant or breast feeding women
- •Age <18 or >40
- •Refuse to sign the consent form
- •Patients with underlying risk of medical disease history: history of diabetes, serious cardiovascular disease, severe infection, alimentary tract hemorrhage, etc.
- •Serum with HIV, syphilis antibody positive
- •Severe mental disease, cognitive disorder patients
- •Other severe system or organ organic disease
- •Participate other clinical experiments in 3 months
- •Ovarian and pituitary dysfunction diseases
- •With some other conditions that doctor propose not to participate
结局指标
主要结局
Intrauterine adhesion patients efficacy evaluation
时间窗: 12 months
Evaluate the efficacy by calculating the thickness of endometrium, the equation is, Efficacy = (thickness of endometrium after treatment - thickness of endometrium before treatment)/thickness of endometrium before treatment \* 100% Classified the efficacy in 4 grade as follow, A. Recovery, efficacy 86% - 100%; B. Obvious improve, efficacy 46% - 85%; C. Improve, efficacy 16% -45%; D. Invalid, efficacy \< 16% Grade A, B, and C is proposed to be effective.
次要结局
- Incision lacuna and incision diverticulum patients efficacy evaluation(12 months)
- Ultrasound of uterus evaluation(12 months)
- Hysteroscopy evaluation(12 months)
- Pain score(12 months)