Clinical trial NCT06224296: 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
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sub-healthy
Hyperlipidemia
Toxic Metal Ions Accumulation
Keywords: DFPP
Blood Purification
Lead sponsor: Shanghai Cell Therapy Group Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Mengchao Cancer Hospital
First posted: 2024-01-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects are self-controlled in each group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory cytokine panel
timeFrame: Baseline, day0, 1, 3, 6 month after DFPP
measure: Blood lipid panel
timeFrame: Baseline, day0, 1, 3, 6 month after DFPP
measure: Toxic metal ions
timeFrame: Baseline, day0
Secondary outcomes:
measure: Immune cells
timeFrame: Baseline, day0, 1, 3, 6 month after DFPP
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mengchao Cancer Hospital
state: Shanghai
Study officials:
References: