NCT04566757

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

September 4, 2020

Last Update Submit

January 11, 2021

Conditions

Age-related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Safety of Umbilical Cord Blood Plasma Infusion

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

    6 months

Secondary Outcomes (2)

  • Assessment of Executive Function

    12 months

  • Assessment of Working Memory

    12 months

Study Arms (1)

Umbilical Cord Plasma Infusion

EXPERIMENTAL

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

Biological: Umbilical Cord Blood Plasma

Interventions

Umbilical Cord Blood PlasmaBIOLOGICAL

Intravenous Infusion of Umbilical Cord Blood Plasma

Umbilical Cord Plasma Infusion

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (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.

    PMID: 28815019BACKGROUND

  • 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: 21886162BACKGROUND

  • 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: 32054965BACKGROUND

  • 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.

    PMID: 24793238BACKGROUND

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 28, 2020

Study Start

March 1, 2021

Primary Completion

December 1, 2021

Study Completion

June 14, 2022

Last Updated

January 13, 2021

Record last verified: 2021-01