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

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.

Study Overview

• Status: Unknown
• Conditions: Age-related Cognitive Decline
• Intervention / Treatment: Biological: Umbilical Cord Blood Plasma

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 65-85 years old
2. Evidence of cognitive decline on neuro-cognitive testing
3. Able to participate in research trial for 12 months
4. Women must have documented menopause or infertility determination
5. Ability to receive intravenous infusions
6. Patient or legally authorized representative able to sign informed consent

Exclusion Criteria:

1. Patients receiving any other investigational biologics or drugs
2. History of transfusion reaction
3. Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)
4. Inability to participate in cognitive or performance testing
5. History of cancer in the last 5 years
6. History of infectious disease within the previous 12 months
7. Severe kidney (eGFR< 30) and heart failure (Class III/IV)
8. History of Human Immunodeficiency Virus Infection
9. History of Hepatitis B, or C
10. History of immunosuppressive therapy
11. History of organ transplantation
12. Difficulty of obtaining peripheral venous access
13. Allergy to histamine blockers

14. Inability to participate in the clinical trial at any data collection and end points

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American Academy of Regenerative Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 14, 2022

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AARM2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No