The Exploratory Study About the Effect of Using Double Filtration Plasmapheresis (DFPP) Removing Inflammatory Cytokines, Lipids and Toxic Metal Ions in Peripheral Blood in Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Blood lipid panel
研究概览
简要总结
This study investigates whether using Double Filtration Plasmapheresis (DFPP) could improve the overall health of adults through removing inflammatory cytokines, lipids and toxic metal ions from peripheral blood. It's also postulated that DFPP could boost immune cells through removing certain inflammatory cytokines and blood lipids.
详细描述
In this study, 3 groups of subjects will be recruited based on the indications of using DFPP. Estimated 100 sub-healthy subjects will be enrolled in the Group A (inflammatory cytokine group), the inflammatory cytokine panel will be tested at baseline, immediately and 1, 3, 6 months after using DFPP. Similarly estimated 100 subjects with elevated blood lipid or cholesterol will be enrolled in Group B (lipids group), the lipid panel will be tested at the same timeline as Group A. Estimated 50 subjects who are likely to have toxic metal ions accumulated (eg. using make-up for long term, working exposure) will be enrolled in Group C (toxic metal ions group), the specific metal ions will be tested before and after using DFPP. Tests related to immune cells will also be conducted in Group A and B at baseline, immediately and 1, 3, 6 months after using DFPP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/females of 18 to 85 years of age. For Group B, subjects should have elevated blood lipid or cholesterol, which could be a. hyperlipidemia; b. higher than the normal range but not high enough to be diagnosed as hyperlipidemia. Able to provide written Informed Consent. Able to follow verbal and written study directions.
排除标准
- •Have sever liver and kidney dysfunction. Have cardiopulmonary insufficiency. Have solid or blood tumor. Pregnancy or breastfeeding women.
结局指标
主要结局
Blood lipid panel
时间窗: Baseline, day0, 1, 3, 6 month after DFPP
Total cholesterol, total triglycerides, low-density lipoprotein(LDL), high-density lipoprotein(HDL), lipoprotein(a)(subjected to change)
Inflammatory cytokine panel
时间窗: Baseline, day0, 1, 3, 6 month after DFPP
IL-2,IL-4,IL-6,IL-10, TNF-a, IFN-r, hs CRP(subjected to change)
Toxic metal ions
时间窗: Baseline, day0
Lead, mercury etc based on the specific exposure
次要结局
- Immune cells(Baseline, day0, 1, 3, 6 month after DFPP)