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The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
Sponsor: Dobri Kiprov
Summary
The goal of this clinical trial is to assure the safety of long term therapeutic plasma exchange (TPE) with and without Intravenous Immunoglobulin (IVIG) and its effects on biomarkers and epigenetic biologic clocks in forty individuals. The main question is to assure the safety from long term TPE using changes in clinical and laboratory outcomes and also evaluating changes on additional blood biomarkers and epigenetic clocks during and after TPE treatment. Researchers will compare the TPE treatment group to the Sham treatment group to identify changes due to TPE. Participants will receive six TPE or Sham treatments over one of two treatment schedules and may receive IVIG with treatment.
Official title: A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
Key Details
Gender
All
Age Range
50 Years - 95 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-09-12
Completion Date
2025-08
Last Updated
2024-08-02
Healthy Volunteers
Yes
Conditions
Interventions
Sham
The patient's blood will not circulate through the apheresis machine. The patient will receive approximately 250 cc of normal saline during each sham pheresis procedure.
Therapeutic Plasma Exchange
Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components. The plasma is removed and the blood cells are returned to the patient along with replacement fluids, most commonly 5% human albumin in normal saline.
IVIG
Intravenous Immunoglobulin
Locations (1)
Global Apheresis
Mill Valley, California, United States