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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sub-healthy
• Hyperlipidemia
• Toxic Metal Ions Accumulation

Interventions

Type	Name	Description
DEVICE	DFPP	One session of blood purification using DFPP to remove inflammatory cytokines in peripheral blood.
DEVICE	DFPP	One session of blood purification using DFPP to remove lipids in peripheral blood.
DEVICE	DFPP	One session of blood purification using DFPP to remove toxic metal ions.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-12-31
• Completion: 2025-03-01
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

1 site across 1 country: China