Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Purity and Function of NK cells
研究概览
简要总结
Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.
详细描述
Endometriosis (EMs) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. The pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. It is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (NK) cytotoxicity. In this study, routine therapy combined with NK cell therapy was used in the treatment of severe endometriosis. The clinical data were collected to confirm the efficacy and safety of NK cell therapy. It is expected to provide a new way of thinking and method for the clinical treatment of EMs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagonsed as endometriosis stage III~IV
- •Age ≥18 years ≤ 45 years at the time of informed consent
- •With indications for conservative endometriosis surgery
- •With complete clinical data
排除标准
- •Severe allergy to drugs
- •Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents)
- •With serious cardiac, cerebrovascular diseases and liver, kidney disorders
- •With a history of severe mental illness
研究组 & 干预措施
Conventional treatment group
GnRHa combained with reverse addition therapy
干预措施: GnRHa combained with reverse addition therapy (Drug)
Conventional treatment and Autologous NK cells therapy
GnRHa combained with reverse addition therapy and NK cell combined treatment group
干预措施: Autologous NK cell therapy (Biological)
Conventional treatment and Autologous NK cells therapy
GnRHa combained with reverse addition therapy and NK cell combined treatment group
干预措施: GnRHa combained with reverse addition therapy (Drug)
结局指标
主要结局
Purity and Function of NK cells
时间窗: once per three months
The purity and function of NK cells will be measured by flow cytometry.
Incidence of Treatment-Emergent Adverse Events [Safety]
时间窗: 3 months after treatment
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0
次要结局
- Endocrine hormone levels(every three months, up to 36 months)
- Pain score(every three months, up to 36 months)
- The percent of pregnancy(36 months)