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

Primary Purpose

Age-related Cognitive Decline

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Umbilical Cord Blood Plasma
Sponsored by
American Academy of Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cognitive Decline

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Umbilical Cord Plasma Infusion

    Arm Description

    Infusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months

    Outcomes

    Primary Outcome Measures

    Safety of Umbilical Cord Blood Plasma Infusion
    Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion

    Secondary Outcome Measures

    Assessment of Executive Function
    Assessment of executive function by Wisconsin Card Sorting Test (WCST)
    Assessment of Working Memory
    Assessment of working memory by Wechsler Memory Scale

    Full Information

    First Posted
    September 4, 2020
    Last Updated
    January 11, 2021
    Sponsor
    American Academy of Regenerative Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04566757
    Brief Title
    Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
    Official Title
    Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    June 14, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    American Academy of Regenerative Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-related Cognitive Decline

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Umbilical Cord Plasma Infusion
    Arm Type
    Experimental
    Arm Description
    Infusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months
    Intervention Type
    Biological
    Intervention Name(s)
    Umbilical Cord Blood Plasma
    Intervention Description
    Intravenous Infusion of Umbilical Cord Blood Plasma
    Primary Outcome Measure Information:
    Title
    Safety of Umbilical Cord Blood Plasma Infusion
    Description
    Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Assessment of Executive Function
    Description
    Assessment of executive function by Wisconsin Card Sorting Test (WCST)
    Time Frame
    12 months
    Title
    Assessment of Working Memory
    Description
    Assessment of working memory by Wechsler Memory Scale
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28815019
    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.
    Results Reference
    background
    PubMed Identifier
    21886162
    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.
    Results Reference
    background
    PubMed Identifier
    32054965
    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.
    Results Reference
    background
    PubMed Identifier
    24793238
    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.
    Results Reference
    background

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

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