A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Rate of change to blood epigenetic clock from TPE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
TPE Monthly
will receive 6 monthly TPE procedures (TOTAL 6 treatments)
Intervention: Therapeutic Plasma Exchange (Device)
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)
Intervention: Therapeutic Plasma Exchange (Device)
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)
Intervention: Therapeutic Plasma Exchange (Device)
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)
Intervention: IVIG (Drug)
Sham
Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments)
Intervention: Sham (Device)
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
- 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 short-form health survey score(after study completion, an average of 2 years)
- Change in balance time(after study completion, an average of 2 years)
Investigators
Dobri Kiprov
Chief Medical Officer
Global Apheresis, Inc.