Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Blood serum sample
研究概览
简要总结
The purpose of this study is to investigating the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely UC-MSCs treatment, secretomes treatment, UC-MSCs and secretomes treatment, and control.
详细描述
The investigator hypothesized that PCOS patients with insulin resistance given combination of UC-MSCs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle and fertility. All group will be observed every 1,3, and 6 months after injection.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
- •Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score >8)
- •Patients with Free Androgen Index (FAI) >4 and ovary polycystic from USG transvaginal
- •Patients with Homeostatic (HOMA) IR score ≥ 1.7
排除标准
- •Patients who are allergic to component of WJ-MSC or Secretome.
- •Patients who are not currently on hormon treatment of other resistance treatment.
- •Refusing or not participating in part / all of the research process.
- •Patients with positive diagnosis of hepatitis A,B,C, and HIV
研究组 & 干预措施
WJ-MSCs
Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
干预措施: UC-MSCs (Biological)
Secretomes
Patients will be given tablet (placebo) once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
干预措施: Secretomes (Biological)
WJ-MSCs and Secretomes
Patients will be given tablet (placebo) once for 30 days, IV 0.3 million kg/bb UC-MSCs once, and nasal drop 0.5 ml/day (Secretomes) for 30 days.
干预措施: UC-MSCs and Secretomes (Biological)
Control
Patients will be given Metformin once for 30 days, IV placebo (NaCl 0.9%) once, and nasal drop 0.5 ml/day (growth medium) for 30 days.
干预措施: Control (Biological)
结局指标
主要结局
Blood serum sample
时间窗: Follicular phase on day 10-12
Sampling of the subject's blood serum will be carried out during the follicular phase on day 10-12.
Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
时间窗: Follicular phase on day 10-12, and 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
Leptin and Adiponectine Profile
时间窗: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
Free Androgen index (FAI)
时间窗: Follicular phase on day 10-12
Free Androgen index (FAI) is calculated by total testosterone x100/SHBG
Insulin, Glucose Plasma, and Insulin Resistance
时间窗: Follicular phase on day 10-12
insulin resistance is calculated by the method: HOMA: HOMA-IR = (insulin x glucose) / 22.5 and HOMA-ß = (20 x insulin) / glucose - 3.5.
TNFα, IL-1 β, IL-6, IL-10 Profile
时间窗: 1,3,6 months after stem cells
Parameter in testing the cytokine/adipokine/hormone profile
次要结局
未报告次要终点