The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
- Conditions
- Aging
- Interventions
- Registration Number
- NCT06534450
- Lead Sponsor
- Dobri Kiprov
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Subjects over 50 years of age with or without chronic inflammatory condition
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TPE Bimonthly Therapeutic Plasma Exchange will receive 2 TPE procedures in one week. The same treatment will be repeated on a monthly basis two more times (Two treatments per month for three months to total 6 treatments) Sham Sham Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments) TPE Monthly Therapeutic Plasma Exchange will receive 6 monthly TPE procedures (TOTAL 6 treatments) TPE Bimonthly with IVIG Therapeutic Plasma Exchange will receive 2 TPE procedures followed by 2 gm of IVIG in one week. The same treatment will be repeated on a monthly basis twice more. (Two TPE procedures per month for three months - total of 6 treatments) TPE Bimonthly with IVIG IVIG will receive 2 TPE procedures followed by 2 gm of IVIG in one week. The same treatment will be repeated on a monthly basis twice more. (Two TPE procedures per month for three months - total of 6 treatments)
- Primary Outcome Measures
Name Time Method 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.
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
- Secondary Outcome Measures
Name Time Method 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 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
Change in balance time after study completion, an average of 2 years The objective is to compare changes in balance time from TPE
Trial Locations
- Locations (1)
Global Apheresis
🇺🇸Mill Valley, California, United States