Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT04566757
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-06-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Umbilical Cord Blood Plasma Infusion', 'timeFrame': '6 months', 'description': 'Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion'}], 'secondaryOutcomes': [{'measure': 'Assessment of Executive Function', 'timeFrame': '12 months', 'description': 'Assessment of executive function by Wisconsin Card Sorting Test (WCST)'}, {'measure': 'Assessment of Working Memory', 'timeFrame': '12 months', 'description': 'Assessment of working memory by Wechsler Memory Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Cognitive Decline']}, 'referencesModule': {'references': [{'pmid': '28815019', 'type': 'BACKGROUND', 'citation': 'Horowitz AM, Villeda SA. Therapeutic potential of systemic brain rejuvenation strategies for neurodegenerative disease. F1000Res. 2017 Aug 1;6:1291. doi: 10.12688/f1000research.11437.1. eCollection 2017.'}, {'pmid': '21886162', 'type': 'BACKGROUND', 'citation': 'Villeda SA, Luo J, Mosher KI, Zou B, Britschgi M, Bieri G, Stan TM, Fainberg N, Ding Z, Eggel A, Lucin KM, Czirr E, Park JS, Couillard-Despres S, Aigner L, Li G, Peskind ER, Kaye JA, Quinn JF, Galasko DR, Xie XS, Rando TA, Wyss-Coray T. The ageing systemic milieu negatively regulates neurogenesis and cognitive function. Nature. 2011 Aug 31;477(7362):90-4. doi: 10.1038/nature10357.'}, {'pmid': '32054965', 'type': 'BACKGROUND', 'citation': "Kang S, Moser VA, Svendsen CN, Goodridge HS. Rejuvenating the blood and bone marrow to slow aging-associated cognitive decline and Alzheimer's disease. Commun Biol. 2020 Feb 13;3(1):69. doi: 10.1038/s42003-020-0797-4."}, {'pmid': '24793238', 'type': 'BACKGROUND', 'citation': 'Villeda SA, Plambeck KE, Middeldorp J, Castellano JM, Mosher KI, Luo J, Smith LK, Bieri G, Lin K, Berdnik D, Wabl R, Udeochu J, Wheatley EG, Zou B, Simmons DA, Xie XS, Longo FM, Wyss-Coray T. Young blood reverses age-related impairments in cognitive function and synaptic plasticity in mice. Nat Med. 2014 Jun;20(6):659-63. doi: 10.1038/nm.3569. Epub 2014 May 4.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the safety of Umbilical Cord Blood Plasma infusions in elderly adults regardless of gender, with age-related cognitive decline. Human clinical data of the use of young plasma appear to show beneficial cognitive effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 65-85 years old\n2. Evidence of cognitive decline on neuro-cognitive testing\n3. Able to participate in research trial for 12 months\n4. Women must have documented menopause or infertility determination\n5. Ability to receive intravenous infusions\n6. Patient or legally authorized representative able to sign informed consent\n\nExclusion Criteria:\n\n1. Patients receiving any other investigational biologics or drugs\n2. History of transfusion reaction\n3. Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)\n4. Inability to participate in cognitive or performance testing\n5. History of cancer in the last 5 years\n6. History of infectious disease within the previous 12 months\n7. Severe kidney (eGFR\\< 30) and heart failure (Class III/IV)\n8. History of Human Immunodeficiency Virus Infection\n9. History of Hepatitis B, or C\n10. History of immunosuppressive therapy\n11. History of organ transplantation\n12. Difficulty of obtaining peripheral venous access\n13. Allergy to histamine blockers\n14. Inability to participate in the clinical trial at any data collection and end points\n\n \\-"}, 'identificationModule': {'nctId': 'NCT04566757', 'briefTitle': 'Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline', 'organization': {'class': 'OTHER', 'fullName': 'American Academy of Regenerative Medicine'}, 'officialTitle': 'Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline', 'orgStudyIdInfo': {'id': 'AARM2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Umbilical Cord Plasma Infusion', 'description': 'Infusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months', 'interventionNames': ['Biological: Umbilical Cord Blood Plasma']}], 'interventions': [{'name': 'Umbilical Cord Blood Plasma', 'type': 'BIOLOGICAL', 'description': 'Intravenous Infusion of Umbilical Cord Blood Plasma', 'armGroupLabels': ['Umbilical Cord Plasma Infusion']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Academy of Regenerative Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}