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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
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.
Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components.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.
Intravenous Immunoglobulin
Global Apheresis
Mill Valley, California, United States
Adverse events and unanticipated events total for TPE safety
The primary objective is to assure the safety of long term TPE
Time frame: through study completion, an average of 1 year
Rate of change to blood epigenetic clock from TPE
The objective is to compare the rate of change to the blood epigenetic clock from TPE.
Time frame: through study completion, an average of 1 year
Change in hand grip strength
The objective is to compare changes in hand grip strength from TPE
Time frame: after study completion, an average of 2 years
Change in time up and go test
The objective is to compare changes in the time up and go test from TPE
Time frame: after study completion, an average of 2 years
Change in balance time
The objective is to compare changes in balance time from TPE
Time frame: after study completion, an average of 2 years
Change in short-form health survey score
The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better
Time frame: after study completion, an average of 2 years
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