AgingNCT05004220
Effects of Plasmapheresis on Aging Biomarkers
An observational study of Aging and Plasmapheresis, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Plasmapheresis
- What is being tested?
- Plasmapheresis
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Apr 2021to 10 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Generally healthy volunteer subjects age 40 - 60
- 50:50 man and woman
Who cannot join
- Subjects excluded from plasma donation protocols (serious illness, infection, etc)
- Subjects undergoing stronger anti-aging interventions
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Charles University, Medical Faculty in Hradec Kralove
Hradec Králové
About this study
Official title: 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.
- Conditions
- Aging, Plasmapheresis
- Being tested
- Plasmapheresis
- Keywords
- Aging, Plasmapeheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmapheresisProcedure or surgery
Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 consists of first time donors undergoing all 8 tracked plasmaphereses. Receives: Procedure: Plasmapheresis | |
| Group 2 | Group 2 consists of first time donors undergoing only last 4 plasmaphereses, serving as control for the first 4 donations. Receives: Procedure: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 8 months
Secondary outcomes (5)
Significant change of biological age according to epigenetic clock after 8 plasmaphereses
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.
Measured: Through study completion, an average of 8 months
Significant change of the proteomic profile after 8 plasmaphereses
Proteomic analysis showing signs of a rejuvenated proteostasis in the plasma donors after 8 cycles of plasmapheresis.
Measured: Through study completion, an average of 8 months
Significant change of the proteomic profile after 4 plasmaphereses
Proteomic analysis showing signs of a rejuvenated proteostasis in the plasma donors after 8 cycles of plasmapheresis.
Measured: Through study completion, an average of 8 months
Significant change of the biological age according to a blood biochemistry clock after 8 plasmaphereses
Blood biochemistry clock showing phenotype of a younger individual in the plasma donors after 8 cycles of plasmapheresis.
Measured: Through study completion, an average of 8 months
Significant change of the biological age according to a blood biochemistry clock after 4 plasmaphereses
Blood biochemistry clock showing phenotype of a younger individual in the plasma donors after 8 cycles of plasmapheresis.
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start6 Apr 2021
- Primary completion16 Aug 2021
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Hradec Kralove, Longevitytech.fund a.s., Clock Foundation, AGECURVE LIMITED
- Responsible party
- Principal investigator, Pavel Borsky, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004220
- Sponsor's protocol ID
- 202103 P07
- Status last verified
- Sep 2023
- First submitted
- 30 Jul 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studie Vlivu darování krevní Plazmy - Plasmapheresis. Study of the Plasma Donation Effect - Plasmapheresis
- ClinicalTrials.gov ID
- NCT05004220
- Acronym / sponsor ID
- 202103 P07
- Conditions
- Aging, Plasmapheresis
- Keywords
- Aging, Plasmapeheresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Hradec Kralove, Longevitytech.fund a.s., Clock Foundation, AGECURVE LIMITED
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: PlasmapheresisGroup 1 consists of first time donors undergoing all 8 tracked plasmaphereses. |
| Group 2 | – | Procedure: PlasmapheresisGroup 2 consists of first time donors undergoing only last 4 plasmaphereses, serving as control for the first 4 donations. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Generally healthy volunteer subjects age 40 - 60
- 50:50 man and woman
Key exclusion criteria (2 listed)
- Subjects excluded from plasma donation protocols (serious illness, infection, etc)
- Subjects undergoing stronger anti-aging interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmapheresisProcedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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.
5 secondary outcomes
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 proteomic profile after 8 plasmaphereses
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Plasmapheresis, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant change of biological age according to epigenetic clock after 8 plasmaphereses (time frame: Through study completion, an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.