Effects of Plasmapheresis on Aging Biomarkers

September 4, 2023 updated by: Pavel Borsky, Charles University, Czech Republic

Studie Vlivu darování krevní Plazmy - Plasmapheresis. Study of the Plasma Donation Effect - Plasmapheresis

The aim of the study is to evaluate the effect of plasmapheresis (repeated plasma withdrawals) on selected health indicators (hematological, biochemical, immunological and indicators of biological age) of plasma donors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Králové, Czechia
        • Charles University, Medical Faculty in Hradec Kralove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

41 donors are welcomed to begin with the study. The participants are divided into 2 groups (Group 1 = therapeutic, Group 2 = half control) using stratified randomization, major criteria being chronological age and BMI, minor criteria being illness/medication, smoking, COVID in past 3 months, covid vaccination.

Group 1 consists of 28 participants (14 female, 14 male). Group 2 consists of 13 participants (7 female, 6 male). We suppose that the number of participants will decline during each phase of the study, approx. 10% before it even starts, 10% in the middle, 10% in the end. The goal is to have more than 30 participants finishing the study.

Description

Inclusion Criteria:

  1. Generally healthy volunteer subjects age 40 - 60
  2. 50:50 man and woman

Exclusion Criteria:

  1. Subjects excluded from plasma donation protocols (serious illness, infection, etc)
  2. Subjects undergoing stronger anti-aging interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Group 1 consists of first time donors undergoing all 8 tracked plasmaphereses.
Procedure: Plasmapheresis
Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.
Group 2
Group 2 consists of first time donors undergoing only last 4 plasmaphereses, serving as control for the first 4 donations.
Procedure: Plasmapheresis
Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant change of biological age according to epigenetic clock after 8 plasmaphereses
Time Frame: Through study completion, an average of 8 months
Significant change of the epigenetic age of the plasma donors after 8 cycles of plasmapheresis conducted or a slower increase of the biological age throughout the study than the increase of the chronological age.
Through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant change of biological age according to epigenetic clock after 8 plasmaphereses
Time Frame: Through study completion, an average of 8 months
Significant change of the epigenetic age of the plasma donors after 4 cycles of plasmapheresis conducted or a slower increase of the biological age throughout the study than the increase of the chronological age.
Through study completion, an average of 8 months
Significant change of the proteomic profile after 8 plasmaphereses
Time Frame: Through study completion, an average of 8 months
Proteomic analysis showing signs of a rejuvenated proteostasis in the plasma donors after 8 cycles of plasmapheresis.
Through study completion, an average of 8 months
Significant change of the proteomic profile after 4 plasmaphereses
Time Frame: Through study completion, an average of 8 months
Proteomic analysis showing signs of a rejuvenated proteostasis in the plasma donors after 8 cycles of plasmapheresis.
Through study completion, an average of 8 months
Significant change of the biological age according to a blood biochemistry clock after 8 plasmaphereses
Time Frame: Through study completion, an average of 8 months
Blood biochemistry clock showing phenotype of a younger individual in the plasma donors after 8 cycles of plasmapheresis.
Through study completion, an average of 8 months
Significant change of the biological age according to a blood biochemistry clock after 4 plasmaphereses
Time Frame: Through study completion, an average of 8 months
Blood biochemistry clock showing phenotype of a younger individual in the plasma donors after 8 cycles of plasmapheresis.
Through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

University Hospital Hradec Kralove
Longevitytech.fund a.s.
Clock Foundation
AGECURVE LIMITED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

August 16, 2021

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202103 P07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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