Effects of Plasmapheresis on Aging Biomarkers

Completed

• Conditions: Aging; Plasmapheresis
• Interventions: Procedure: Plasmapheresis

• Registration Number: NCT05004220
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-13
• Primary Completion: 2021-08-16
• Study Completion: 2023-02-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Plasmapheresis	Group 1 consists of first time donors undergoing all 8 tracked plasmaphereses.
Group 2	Plasmapheresis	Group 2 consists of first time donors undergoing only last 4 plasmaphereses, serving as control for the first 4 donations.

Primary Outcome Measures

Name	Time	Method
Significant change of biological age according to epigenetic clock after 8 plasmaphereses	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.

Secondary Outcome Measures

Name	Time	Method
Significant change of the proteomic profile after 4 plasmaphereses	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.
Significant change of the biological age according to a blood biochemistry clock after 4 plasmaphereses	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.
Significant change of biological age according to epigenetic clock after 8 plasmaphereses	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.
Significant change of the proteomic profile after 8 plasmaphereses	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.
Significant change of the biological age according to a blood biochemistry clock after 8 plasmaphereses	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.

Trial Locations

Locations (1)

Charles University, Medical Faculty in Hradec Kralove; 🇨🇿 Hradec Králové, Czechia