Removal of Microplastics, Nanoplastics, and PFAS From Human Peripheral Blood Via Double-Filtration Plasmapheresis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Circulating Microplastic and Nanoplastic Particle Concentration
研究概览
简要总结
This prospective, non-interventional, within-subject paired biomarker study will evaluate whether circulating microplastic and nanoplastic-associated particle concentrations and PFAS concentrations in peripheral blood change after clinically prescribed double-filtration plasmapheresis (DFPP). Twenty adult volunteers already undergoing DFPP independent of research participation will provide paired pre- and post-treatment blood samples. The primary endpoints are within-participant change in microplastic and nanoplastic-associated particle concentration measured by nano-flow cytometry with Nile Red staining, and PFAS concentration measured by LC-MS/MS. An exploratory subset of five participants will undergo Py-GC-MS analysis of paired blood samples and DFPP eluate to evaluate polymer-specific mass changes and the presence of plastic polymers in eluate, and LC-MS/MS to evaluate the presence of PFAS in eluate. DFPP treatment decisions and procedural parameters are determined solely by the treating physician as part of routine care.
详细描述
Background and Rationale:
Microplastics and nanoplastics (MNPs) have been detected in human blood and every major organ. Increasingly, studies associate MNP exposure with a range of health conditions, including cardiovascular disease, metabolic disease, gastrointestinal disease, neurodegenerative disease, and cancer. There has been very little study of clinical approaches to remove MNPs from the human body. Such efforts have been limited in part by challenges in measuring MNPs in human blood, especially nanoplastics, which are too small to be detected by most equipment.
Double-filtration plasmapheresis (DFPP) is an established treatment for dozens of health conditions mediated by substances circulating in plasma. In DFPP, a first filter separates blood cells from plasma, and a second filter removes molecules from plasma according to the filter characteristics. The filtered plasma and blood cells are then recombined and returned to the patient. In 2025, a study showed that the material removed from plasma by a specialized type of DFPP called Inuspheresis with the CE-marked IN300 device includes microplastic molecules.
Per- and polyfluoroalkyl substances (PFAS) are persistent environmental chemicals that can also be measured in human blood and have been associated with a range of health conditions. This study will additionally evaluate whether circulating PFAS concentrations change after DFPP.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Body weight greater than 40 kg (approximately 88 lb)
- •Already independently prescribed DFPP treatment by a qualified treating clinic
- •Able to understand the study and provide voluntary informed consent
- •Willing and able to provide blood samples before and after DFPP treatment
- •Cleared for DFPP by the prescribing clinic
- •Has not had plasmapheresis treatment within the past 7 days
排除标准
- •Not yet prescribed DFPP by a treating clinic
- •Major heart or circulatory problems, such as recent myocardial infarction or hypertensive crisis
- •Serious kidney or liver impairment
- •Blood-clotting disorders or significantly impaired coagulation
- •Active infection, inflammation, or fever
- •Severe frailty or very poor medical condition
- •Anemia with hemoglobin below 8 g/dL
- •Body weight under 40 kg
- •Pregnancy or breastfeeding
- •Determined by the treating clinic to be medically or mentally inappropriate for DFPP
研究组 & 干预措施
DFPP Treatment Group
Adults aged 18 to 80 who have already been independently prescribed DFPP by their treating clinic, independent of research participation. Each participant undergoes one DFPP treatment session with paired pre- and post-treatment blood sampling. A randomly selected subset of five participants will also provide samples for exploratory Py-GC-MS analysis and eluate collection.
干预措施: Double-Filtration Plasmapheresis With the IN300 Apheresis Device (Procedure)
结局指标
主要结局
Change in Circulating Microplastic and Nanoplastic Particle Concentration
时间窗: Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day
Within-subject change in total microplastic and nanoplastic particle concentration in peripheral blood, measured by nano-flow cytometry with Nile Red staining and reported as particles per unit volume, absolute change, percent change, and post/pre ratio. Pre-treatment and post-treatment blood samples are compared within each participant.
Change in Circulating PFAS Concentration
时间窗: Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day
Within-subject change in total quantifiable PFAS concentration in peripheral blood, measured by LC-MS/MS and reported as particles per unit volume, absolute change, percent change, and post/pre ratio. Pre-treatment and post-treatment blood samples are compared within each participant.
次要结局
- Baseline Correlations of MNP and PFAS Levels With Demographic Characteristics(Baseline only, before DFPP)
- Change in Individual PFAS Analyte Concentrations(Baseline and post-treatment within a single treatment day; post-treatment sample collected within 10 minutes of completion of DFPP.)
- Presence and Quantity of PFAS Analytes in DFPP Eluate(During a single DFPP treatment session; eluate collected during DFPP.)
- Association Between Baseline MNP and PFAS Levels(Baseline only, before DFPP.)