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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sub-healthy Hyperlipidemia Toxic Metal Ions Accumulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects are self-controlled in each group.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A: Inflammatory cytokine group

Self-control

Group Type EXPERIMENTAL

DFPP

Intervention Type DEVICE

One session of blood purification using DFPP to remove inflammatory cytokines in peripheral blood.

Group B: Lipid group

Self-control

Group Type EXPERIMENTAL

DFPP

Intervention Type DEVICE

One session of blood purification using DFPP to remove lipids in peripheral blood.

Group C: Toxic metal ions group

Self-control

Group Type EXPERIMENTAL

DFPP

Intervention Type DEVICE

One session of blood purification using DFPP to remove toxic metal ions.

Interventions

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DFPP

One session of blood purification using DFPP to remove inflammatory cytokines in peripheral blood.

Intervention Type DEVICE

DFPP

One session of blood purification using DFPP to remove lipids in peripheral blood.

Intervention Type DEVICE

DFPP

One session of blood purification using DFPP to remove toxic metal ions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.