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Procedure

TPE Monthly for Aging

Phase 3
Waitlist Available
Led By Dobri Kiprov, MD
Research Sponsored by Dobri Kiprov
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Subjects over 50 years of age with or without chronic inflammatory condition
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after study completion, an average of 2 years
Awards & highlights

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.

Who is the study for?
This trial is for forty individuals interested in the safety and effects of long-term plasma exchange on aging. Specific eligibility criteria are not provided, but typically participants would need to be healthy enough for the procedures involved.
What is being tested?
The study tests if long-term therapeutic plasma exchange (TPE), with or without Intravenous Immunoglobulin (IVIG), is safe and how it affects age-related biomarkers and epigenetic clocks. Participants will receive six TPE or Sham treatments over two different schedules, some may also get IVIG.
What are the potential side effects?
Potential side effects are not detailed, but TPE can sometimes cause low blood pressure, light-headedness, allergic reactions, muscle cramps or infections; IVIG might lead to headache, chest discomfort or skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and after study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events and unanticipated events total for TPE safety
Rate of change to blood epigenetic clock from TPE
Secondary study objectives
Change in balance time
Change in hand grip strength
Change in short-form health survey score
+1 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: TPE MonthlyActive Control1 Intervention
will receive 6 monthly TPE procedures (TOTAL 6 treatments)
Group II: TPE Bimonthly with IVIGActive Control2 Interventions
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 III: TPE BimonthlyActive Control1 Intervention
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 IV: ShamPlacebo Group1 Intervention
Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments)

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Who is running the clinical trial?

Dobri KiprovLead Sponsor
CIRCULATE, Inc.UNKNOWN
Dobri Kiprov, MDPrincipal InvestigatorGlobal Apheresis
~13 spots leftby Sep 2025
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