Aging Clinical Trial
Official title:
Studie Vlivu darování krevní Plazmy - Plasmapheresis. Study of the Plasma Donation Effect - Plasmapheresis
| NCT number | NCT05004220 |
| Other study ID # | 202103 P07 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 6, 2021 |
| Est. completion date | February 10, 2023 |
| Verified date | September 2023 |
| Source | Charles University, Czech Republic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | February 10, 2023 |
| Est. primary completion date | August 16, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Charles University, Medical Faculty in Hradec Kralove | Hradec Králové |
| Lead Sponsor | Collaborator |
|---|---|
| Charles University, Czech Republic | AGECURVE LIMITED, Clock Foundation, Longevitytech.fund a.s., University Hospital Hradec Kralove |
Czechia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Through study completion, an average of 8 months | |
| Secondary | 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. | Through study completion, an average of 8 months | |
| Secondary | 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. | Through study completion, an average of 8 months | |
| Secondary | 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. | Through study completion, an average of 8 months | |
| Secondary | 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. | Through study completion, an average of 8 months |
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