Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline

Conditions
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Age-related Cognitive Decline

Intervention / Treatment
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* Biological: Umbilical Cord Blood Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65-85 years old Evidence of cognitive decline on neuro-cognitive testing Able to participate in research trial for 12 months Women must have documented menopause or infertility determination Ability to receive intravenous infusions Patient or legally authorized representative able to sign informed consent Exclusion Criteria: Patients receiving any other investigational biologics or drugs History of transfusion reaction Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.) Inability to participate in cognitive or performance testing History of cancer in the last 5 years History of infectious disease within the previous 12 months Severe kidney (eGFR< 30) and heart failure (Class III/IV) History of Human Immunodeficiency Virus Infection History of Hepatitis B, or C History of immunosuppressive therapy History of organ transplantation Difficulty of obtaining peripheral venous access Allergy to histamine blockers Inability to participate in the clinical trial at any data collection and end points -

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical Cord Plasma Infusion<br>Infusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months | Biological: Umbilical Cord Blood Plasma<br>* Intravenous Infusion of Umbilical Cord Blood Plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Umbilical Cord Blood Plasma Infusion | Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Executive Function | Assessment of executive function by Wisconsin Card Sorting Test (WCST) | 12 months | 
| Assessment of Working Memory | Assessment of working memory by Wechsler Memory Scale | 12 months |