The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics

Dobri Kiprov

Status and phase: Active, not recruiting; Phase 3

Conditions: Aging

Treatments: Device: Therapeutic Plasma Exchange; Device: Sham; Drug: IVIG

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06534450

7348

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

TPE Monthly

Active Comparator group

Description:

will receive 6 monthly TPE procedures (TOTAL 6 treatments)

Treatment:

Device: Therapeutic Plasma Exchange

TPE Bimonthly

Active Comparator group

Description:

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)

Treatment:

Device: Therapeutic Plasma Exchange

TPE Bimonthly with IVIG

Active Comparator group

Description:

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)

Treatment:

Drug: IVIG

Device: Therapeutic Plasma Exchange

Sham

Sham Comparator group

Description:

Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments)

Treatment:

Device: Sham