Effects of Plasmapheresis on Aging Biomarkers

NCT05004220 | Completed

• 1 other identifier: 202103 P07
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Plasmapheresis

Keywords

Aging; Plasmapeheresis

Outcome Measures

Primary Outcomes (1)

• Significant change of biological age according to epigenetic clock after 8 plasmaphereses

  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 Outcomes (5)

• Significant change of biological age according to epigenetic clock after 8 plasmaphereses

  Through study completion, an average of 8 months

• Significant change of the proteomic profile after 8 plasmaphereses

  Through study completion, an average of 8 months

• Significant change of the proteomic profile after 4 plasmaphereses

  Through study completion, an average of 8 months

• Significant change of the biological age according to a blood biochemistry clock after 8 plasmaphereses

  Through study completion, an average of 8 months

• Significant change of the biological age according to a blood biochemistry clock after 4 plasmaphereses

  Through study completion, an average of 8 months

Study Arms (2)

Group 1

Group 1 consists of first time donors undergoing all 8 tracked plasmaphereses.

Procedure: Plasmapheresis

Group 2

Group 2 consists of first time donors undergoing only last 4 plasmaphereses, serving as control for the first 4 donations.

Procedure: Plasmapheresis

Interventions

Plasmapheresis PROCEDURE

Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.

Group 1; Group 2

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Generally healthy volunteer subjects age 40 - 60
• :50 man and woman

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• University Hospital Hradec Kralove: collaborator
• Longevitytech.fund a.s.: collaborator
• Clock Foundation: collaborator
• AGECURVE LIMITED: collaborator

Study Sites (1)

Charles University, Medical Faculty in Hradec Kralove

Hradec Králové, Czechia

Location

MeSH Terms

Interventions

Plasmapheresis

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 13, 2021
• Study Start: April 6, 2021
• Primary Completion: August 16, 2021
• Study Completion: February 10, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)