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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224296
• Other study ID #: BZXJ2401-A-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Shanghai Cell Therapy Group Co.,Ltd
• Contact: Yongqiang Ren
• Phone: 13621247084
• Email: renyq[@]shcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Device:
• DFPP
One session of blood purification using DFPP to remove inflammatory cytokines in peripheral blood.
• DFPP
One session of blood purification using DFPP to remove lipids in peripheral blood.
• DFPP
One session of blood purification using DFPP to remove toxic metal ions.

Locations

Country	Name	City	State
China	Shanghai Mengchao Cancer Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Cell Therapy Group Co.,Ltd	Shanghai Mengchao Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory cytokine panel	IL-2,IL-4,IL-6,IL-10, TNF-a, IFN-r, hs CRP(subjected to change)	Baseline, day0, 1, 3, 6 month after DFPP
Primary	Blood lipid panel	Total cholesterol, total triglycerides, low-density lipoprotein(LDL), high-density lipoprotein(HDL), lipoprotein(a)(subjected to change)	Baseline, day0, 1, 3, 6 month after DFPP
Primary	Toxic metal ions	Lead, mercury etc based on the specific exposure	Baseline, day0
Secondary	Immune cells	TBNK, ROS, PD1/lag3/KLRG1/CD57 etc (subjected to change)	Baseline, day0, 1, 3, 6 month after DFPP