Aging
Conditions
Keywords
Therapeutic Plasma Exchange
Brief 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.
Interventions
DEVICESham
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Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components.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.
DRUGIVIG
Intravenous Immunoglobulin
Sponsors
CIRCULATE, Inc.
Dobri Kiprov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects over 50 years of age with or without chronic inflammatory condition
Exclusion criteria
* Poor peripheral vascular access * Diagnosis of active malignancy * Late-stage Alzheimer's disease Any medical condition which may deteriorate because of plasma exchange procedures. These include, but are not limited to, symptomatic coronary artery disease, congestive heart failure and restrictive pulmonary disease (COPD). The investigators reserve the right to exclude anyone they feel may be harmed in any way by participating in the trial. * Presence of active infection * Alcohol or drug dependency * Psychiatric disorder that will interfere with participation in the study (e.g., schizophrenia, bipolar disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and unanticipated events total for TPE safety | through study completion, an average of 1 year | The primary objective is to assure the safety of long term TPE |
| Rate of change to blood epigenetic clock from TPE | through study completion, an average of 1 year | The objective is to compare the rate of change to the blood epigenetic clock from TPE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hand grip strength | after study completion, an average of 2 years | The objective is to compare changes in hand grip strength from TPE |
| Change in time up and go test | after study completion, an average of 2 years | The objective is to compare changes in the time up and go test from TPE |
| Change in balance time | after study completion, an average of 2 years | The objective is to compare changes in balance time from TPE |
| Change in short-form health survey score | after study completion, an average of 2 years | The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better |
Countries
United States
Outcome results
None listed