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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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TPE Monthly

will receive 6 monthly TPE procedures (TOTAL 6 treatments)

Group Type ACTIVE_COMPARATOR

Therapeutic Plasma Exchange

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Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components.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

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)

Group Type ACTIVE_COMPARATOR

Therapeutic Plasma Exchange

Intervention Type 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 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)

Group Type ACTIVE_COMPARATOR

Therapeutic Plasma Exchange

Intervention Type 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

Intervention Type DRUG

Intravenous Immunoglobulin

Sham

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

IVIG

Intravenous Immunoglobulin

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes