Effects of Plasmapheresis on Aging Biomarkers

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05004220
Collaborator
University Hospital Hradec Kralove (Other), Longevitytech.fund a.s. (Other), Clock Foundation (Other), AGECURVE LIMITED (Other)
41
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4.8
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Plasmapheresis

Study Design

Study Type:
Observational
Anticipated Enrollment :
41 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Studie Vlivu darování krevní Plazmy - Plasmapheresis. Study of the Plasma Donation Effect - Plasmapheresis
Actual Study Start Date :
Apr 6, 2021
Anticipated Primary Completion Date :
Aug 16, 2021
Anticipated Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charles University, Medical Faculty in Hradec Kralove Hradec Králové Czechia

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pavel Borsky, M.D., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT05004220
Other Study ID Numbers:
  • 202103 P07
First Posted:
Aug 13, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pavel Borsky, M.D., Charles University, Czech Republic

Study Results

No Results Posted as of Aug 13, 2021