Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05004220
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2021-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Plasmapheresis on Aging Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010956', 'term': 'Plasmapheresis'}], 'ancestors': [{'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant change of biological age according to epigenetic clock after 8 plasmaphereses', 'timeFrame': 'Through study completion, an average of 8 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Significant change of biological age according to epigenetic clock after 8 plasmaphereses', 'timeFrame': 'Through study completion, an average of 8 months', 'description': '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.'}, {'measure': 'Significant change of the proteomic profile after 8 plasmaphereses', 'timeFrame': 'Through study completion, an average of 8 months', 'description': 'Proteomic analysis showing signs of a rejuvenated proteostasis in the plasma donors after 8 cycles of plasmapheresis.'}, {'measure': 'Significant change of the proteomic profile after 4 plasmaphereses', 'timeFrame': 'Through study completion, an average of 8 months', 'description': 'Proteomic analysis showing signs of a rejuvenated proteostasis in the plasma donors after 8 cycles of plasmapheresis.'}, {'measure': 'Significant change of the biological age according to a blood biochemistry clock after 8 plasmaphereses', 'timeFrame': 'Through study completion, an average of 8 months', 'description': 'Blood biochemistry clock showing phenotype of a younger individual in the plasma donors after 8 cycles of plasmapheresis.'}, {'measure': 'Significant change of the biological age according to a blood biochemistry clock after 4 plasmaphereses', 'timeFrame': 'Through study completion, an average of 8 months', 'description': 'Blood biochemistry clock showing phenotype of a younger individual in the plasma donors after 8 cycles of plasmapheresis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Plasmapeheresis'], 'conditions': ['Aging', 'Plasmapheresis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nGroup 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Generally healthy volunteer subjects age 40 - 60\n2. 50:50 man and woman\n\nExclusion Criteria:\n\n1. Subjects excluded from plasma donation protocols (serious illness, infection, etc)\n2. Subjects undergoing stronger anti-aging interventions'}, 'identificationModule': {'nctId': 'NCT05004220', 'briefTitle': 'Effects of Plasmapheresis on Aging Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Studie Vlivu darování krevní Plazmy - Plasmapheresis. Study of the Plasma Donation Effect - Plasmapheresis', 'orgStudyIdInfo': {'id': '202103 P07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Group 1 consists of first time donors undergoing all 8 tracked plasmaphereses.', 'interventionNames': ['Procedure: Plasmapheresis']}, {'label': 'Group 2', 'description': 'Group 2 consists of first time donors undergoing only last 4 plasmaphereses, serving as control for the first 4 donations.', 'interventionNames': ['Procedure: Plasmapheresis']}], 'interventions': [{'name': 'Plasmapheresis', 'type': 'PROCEDURE', 'description': 'Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Charles University, Medical Faculty in Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, {'name': 'Longevitytech.fund a.s.', 'class': 'UNKNOWN'}, {'name': 'Clock Foundation', 'class': 'UNKNOWN'}, {'name': 'AGECURVE LIMITED', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Pavel Borsky', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}