Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- ovary abcess
研究概览
简要总结
The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.
详细描述
In this study 9 patients with the diagnosis of premature ovarian failure will participate.
The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs.
Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography.
All the patients will be followed for 12 months after cell injection to evaluate any adverse events .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age : 20-39
排除标准
- •liposuction contraindication
- •thyroid dysfunction
- •immune system disease
- •past history of cancer , chemotherapy , radiotherapy
- •HIV+, hepatitis B, C
- •Severe endometriosis
结局指标
主要结局
ovary abcess
时间窗: Up to 12 months
Evaluation the ovary abcess formation up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
ovary mass
时间窗: up to 12months
Evaluation the formation of ovary mass by sonography up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
次要结局
- Pregnancy rate(Up to 12months)
- Follicle Stimulating Hormone (FSH) serum level(Up to 12months)
- Anti-Mullerian Hormone (AMH) serum level(Up to 12months)
- Antral follicle volume(Up to 12months)
- Number of antral follicle(Up to 12months)
- Menstruation recurrence rate(Up to 12 months)