Evaluating DFPP for Microplastic Reduction (DFPP-MNP)

Removal of Microplastics and Nanoplastics From Human Peripheral Blood Via Double-Filtration Plasmapheresis

This prospective, non-interventional, within-subject paired biomarker study will evaluate whether circulating microplastic and nanoplastic-associated particle 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 endpoint is within-participant change in microplastic and nanoplastic-associated particle concentration measured by nano-flow cytometry with Nile Red staining. 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. DFPP treatment decisions and procedural parameters are determined solely by the treating physician as part of routine care.

Study Overview

• Status: Enrolling by invitation
• Conditions: Microplastic and Nanoplastic Particle Burden in Peripheral Blood; Double-Filtration Plasmapheresis
• Intervention / Treatment: Procedure: Double-Filtration Plasmapheresis With the IN300 Apheresis Device

Detailed Description

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.

Study Design:

This is a single-group, open-label, prospective, within-subject observational pilot study. Approximately 20 adult participants who have already been independently prescribed DFPP by their treating clinic will be enrolled.

Procedures:

Each participant provides written informed consent, then undergoes blood sampling shortly before the DFPP treatment session and again within 10 minutes after the end of the treatment session, after approximately 0.75 plasma volumes have been treated. Adverse events and tolerability observations are recorded throughout the treatment encounter. For a randomly selected subset of five participants, additional exploratory analyses will be performed on paired blood samples using pyrolysis-gas chromatography-mass spectrometry (Py-GC-MS), and a sample of DFPP eluate will be collected to assess whether plastic polymers are present in the material removed during treatment.

Analytical Methods:

Primary: Nano-flow cytometry with Nile Red staining, which has been shown in multiple studies to provide detection and counting of microplastic and nanoplastic particles down to approximately 50 nanometers in human blood.

Exploratory: Py-GC-MS for polymer-specific mass quantification in blood and eluate in a five-participant subset.

Statistical Analysis:

The primary analysis will evaluate within-subject change in circulating MNP particle concentration using a paired pre/post design. The primary hypothesis test will be the Wilcoxon matched-pairs signed-rank test. Effect size will be summarized using the median within-participant percent change and geometric mean post/pre ratio with a 95% confidence interval. Based on an approximate paired-analysis power calculation, a sample size of 20 participants provides approximately 80% power to detect a large within-participant reduction on the order of 50%, assuming a two-sided alpha of 0.05 and variability of paired log post/pre ratios not materially exceeding approximately 1.0. Exploratory Py-GC-MS analyses in the five-participant subset are not powered for definitive hypothesis testing; results will be summarized using absolute and percent change. Quality-control procedures include procedural blank review; values at or below the laboratory limit of quantification will be treated conservatively.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Germany
  • Obergünzburg, Germany
    • Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne
• Switzerland
  • Basel, Switzerland, 4051
    • Ayus Medical Basel AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 80 who have already been independently prescribed and medically cleared for DFPP by a qualified treating clinic and who are willing and able to provide paired pre- and post-treatment blood samples.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Double-Filtration Plasmapheresis With the IN300 Apheresis Device; A single clinically prescribed session of double-filtration plasmapheresis using the IN300 Inuspheresis apheresis device. Blood is withdrawn through intravenous access, passed through a primary filter that separates plasma from blood cells, and then through a secondary filter that removes particles according to the filter characteristics. The filtered plasma and blood cells are recombined and returned to the participant. The session treats approximately 0.75 plasma volumes. DFPP is prescribed by and performed at the treating clinic outside the scope of the research study.; Other Names: Plasmapheresis; Inuspheresis; DFPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Circulating Microplastic and Nanoplastic Particle Concentration	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.	Baseline immediately before DFPP and post-treatment within 10 minutes after the DFPP session, within a single treatment day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Plastic Polymer Mass Concentration by Py-GC-MS in a Subset of 5 Participants	Paired pre- and post-treatment blood samples will be analyzed by Py-GC-MS to measure total plastic polymer mass concentration. Results will be summarized by absolute and percent change within participants.	Baseline and post-treatment within a single treatment day; assessed in a randomly selected five-participant subset
Presence of Plastic Polymers in DFPP Eluate	In the same five-participant Py-GC-MS subset, a sample of DFPP eluate will be analyzed by Py-GC-MS to assess whether plastic polymers are detectable in the material removed during treatment.	During a single DFPP treatment session; eluate collected during DFPP
Incidence and Severity of Adverse Events and Tolerability Findings	Incidence, nature, and severity of adverse events and tolerability findings recorded during the treatment encounter, including vital-sign monitoring, symptoms, complications, and any medical interventions required.	During and immediately following the DFPP treatment session
Baseline Correlations of MNP Levels With Demographic Characteristics	Exploratory analysis examining whether pre-treatment MNP levels in peripheral blood are associated with participant demographic characteristics. This outcome does not test treatment efficacy.	Baseline only, before DFPP
Concordance in Direction of Change Between Nano-Flow Cytometry Particle Counts and Py-GC-MS Polymer Mass	Exploratory analysis examining whether the change in MNP levels measured by nano-flow cytometry is in the same direction as the change measured by Py-GC-MS. Concordance will be summarized descriptively; no formal hypothesis testing is planned.	Baseline and post-treatment within a single treatment day; Py-GC-MS assessed in a subset of participants

Collaborators and Investigators

• Sponsor: Efforia, Inc
• Collaborators: Proxima Health
• Investigators: Study Director: Michael Petegorsky, Proxima Health; Study Director: Matthew Amsden, Efforia, Inc; Principal Investigator: Jordi Petriz, PhD, Institut de Recerca Germans Trias i Pujol (IGTP); Principal Investigator: Stefan Bornstein, MD, University Hospital Carl Gustav Carus, Technische Universitaet Dresden

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: apheresis; plasmapheresis; DFPP; microplastics; nanoplastics; double-filtration plasmapheresis; Inuspheresis; IN300; nano-flow cytometry; Py-GC-MS
• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Plasmapheresis
• Other Study ID Numbers: 91252; Efforia-DFPP-MNP-Pilot (Other Identifier: Efforia internal protocol identifier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual-level results will be returned directly to participants. Aggregate and de-identified findings will be published or otherwise made publicly available after study completion. No formal plan is currently established to share individual participant data with external researchers for this pilot study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No