The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Aging
In brief
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.
Key facts
- Study ID
- NCT06534450
- Run by
- Dobri Kiprov
- People needed
- 40
- Starts
- 2022-09-12
- Expected to finish
- 2025-08-01
- Last updated by the study team
- 2024-08-02
Who can join
Age: 50 and older, up to 95. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects over 50 years of age with or without chronic inflammatory condition
You may not qualify if…
- 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)
Where it is running
- Global Apheresis — Mill Valley, California, United States
Full record on ClinicalTrials.gov
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