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

NCT06534450 | Active Not Recruiting Phase 3 FDA Device

• 1 other identifier: 7348
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Therapeutic Plasma Exchange

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in hand grip strength

  after study completion, an average of 2 years

• Change in time up and go test

  after study completion, an average of 2 years

• Change in balance time

  after study completion, an average of 2 years

• Change in short-form health survey score

  after study completion, an average of 2 years

Study Arms (4)

TPE Monthly

ACTIVE COMPARATOR

will receive 6 monthly TPE procedures (TOTAL 6 treatments)

Device: Therapeutic Plasma Exchange

TPE Bimonthly

ACTIVE COMPARATOR

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

TPE Bimonthly with IVIG

ACTIVE COMPARATOR

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; Drug: IVIG

Sham

SHAM COMPARATOR

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

Device: Sham

Interventions

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.

Sham

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.

TPE Bimonthly; TPE Bimonthly with IVIG; TPE Monthly

IVIG DRUG

Intravenous Immunoglobulin

TPE Bimonthly with IVIG

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Dobri Kiprov: lead
• CIRCULATE, Inc.: collaborator

Study Sites (1)

Global Apheresis

Mill Valley, California, 94941, United States

Location

Related Publications (1)

• Fuentealba M, Kiprov D, Schneider K, Mu WC, Kumaar PA, Kasler H, Burton JB, Watson M, Halaweh H, King CD, Yuksel ZS, Roska-Pamaong C, Schilling B, Verdin E, Furman D. Multi-Omics Analysis Reveals Biomarkers That Contribute to Biological Age Rejuvenation in Response to Single-Blinded Randomized Placebo-Controlled Therapeutic Plasma Exchange. Aging Cell. 2025 Aug;24(8):e70103. doi: 10.1111/acel.70103. Epub 2025 May 27.

  PMID: 40424097 DERIVED

MeSH Terms

Interventions

Plasma Exchange; Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dobri Kiprov, MD

  Global Apheresis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 2, 2024
• Study Start: September 12, 2022
• Primary Completion: November 30, 2023
• Study Completion: August 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

US (1)