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

January 16, 2024 updated by: Shanghai Cell Therapy Group Co.,Ltd
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200240
        • Shanghai Mengchao Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yongqiang Ren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Inflammatory cytokine group
Self-control
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.
Experimental: Group B: Lipid group
Self-control
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.
Experimental: Group C: Toxic metal ions group
Self-control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokine panel
Time Frame: 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)
Baseline, day0, 1, 3, 6 month after DFPP
Blood lipid panel
Time Frame: 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)
Baseline, day0, 1, 3, 6 month after DFPP
Toxic metal ions
Time Frame: Baseline, day0
Lead, mercury etc based on the specific exposure
Baseline, day0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Cell Therapy Group Co.,Ltd

Collaborators

Shanghai Mengchao Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZXJ2401-A-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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