Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06534450

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Apheresis

Mill Valley, California, 94941, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SHAM

Device

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.

Therapeutic plasma exchange

Device

Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components.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.

IVIG

Drug

Intravenous Immunoglobulin

Primary outcomes

  1. Adverse events and unanticipated events total for TPE safety

    Time frame: through study completion, an average of 1 year

    The primary objective is to assure the safety of long term TPE

  2. Rate of change to blood epigenetic clock from TPE

    Time frame: 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 outcomes

  1. Change in hand grip strength

    Time frame: after study completion, an average of 2 years

    The objective is to compare changes in hand grip strength from TPE

  2. Change in time up and go test

    Time frame: after study completion, an average of 2 years

    The objective is to compare changes in the time up and go test from TPE

  3. Change in balance time

    Time frame: after study completion, an average of 2 years

    The objective is to compare changes in balance time from TPE

  4. Change in short-form health survey score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dobri Kiprov

Industry

Collaborators

  • CIRCULATE, Inc.

Registry information

Official study title

A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.