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

A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Device: Therapeutic Plasma Exchange; Drug: IVIG; Device: Sham

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Mill Valley, California, United States, 94941
      • Global Apheresis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TPE Monthly; will receive 6 monthly TPE procedures (TOTAL 6 treatments)	Device: Therapeutic Plasma Exchange; 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.
Active Comparator: TPE Bimonthly; 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)	Device: Therapeutic Plasma Exchange; 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.
Active Comparator: TPE Bimonthly with 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)	Device: Therapeutic Plasma Exchange; 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.; Drug: IVIG; Intravenous Immunoglobulin
Sham Comparator: Sham; Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments)	Device: Sham; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and unanticipated events total for TPE safety	The primary objective is to assure the safety of long term TPE	through study completion, an average of 1 year
Rate of change to blood epigenetic clock from TPE	The objective is to compare the rate of change to the blood epigenetic clock from TPE.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hand grip strength	The objective is to compare changes in hand grip strength from TPE	after study completion, an average of 2 years
Change in time up and go test	The objective is to compare changes in the time up and go test from TPE	after study completion, an average of 2 years
Change in balance time	The objective is to compare changes in balance time from TPE	after study completion, an average of 2 years
Change in short-form health survey score	The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better	after study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Dobri Kiprov
• Collaborators: CIRCULATE, Inc.
• Investigators: Principal Investigator: Dobri Kiprov, MD, Global Apheresis

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Therapeutic Plasma Exchange
• Other Study ID Numbers: 7348

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No