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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06224296

Enrollment

250

Registered

2024-01-25

Start date

2024-03-01

Completion date

2025-03-01

Last updated

2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Sub-healthy, Toxic Metal Ions Accumulation

Keywords

DFPP, Blood Purification

Brief summary

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.

Detailed description

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.

Interventions

DEVICEDFPP

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Subjects are self-controlled in each group.

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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.

Exclusion criteria

* Have sever liver and kidney dysfunction. Have cardiopulmonary insufficiency. Have solid or blood tumor. Pregnancy or breastfeeding women.

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory cytokine panel	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)
Blood lipid panel	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)
Toxic metal ions	Baseline, day0	Lead, mercury etc based on the specific exposure

Secondary

Measure	Time frame	Description
Immune cells	Baseline, day0, 1, 3, 6 month after DFPP	TBNK, ROS, PD1/lag3/KLRG1/CD57 etc (subjected to change)

Countries

China

Contacts

Primary ContactYongqiang Ren

renyq@shcell.com13621247084

Backup ContactMeina Jiang

jiangmn@shcell.com18616900240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026