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

Not Applicable

Not yet recruiting

• Conditions: Sub-healthy; Toxic Metal Ions Accumulation; Hyperlipidemia
• Interventions: Device: DFPP

• Registration Number: NCT06224296
• Lead Sponsor: Shanghai Cell Therapy Group Co.,Ltd

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Last Update Submitted: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Study Start: 2024-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A: Inflammatory cytokine group	DFPP	Self-control
Group B: Lipid group	DFPP	Self-control
Group C: Toxic metal ions group	DFPP	Self-control

Primary Outcome Measures

Name	Time	Method
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)
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)
Toxic metal ions	Baseline, day0	Lead, mercury etc based on the specific exposure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Mengchao Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China