Trial | NCT04566757  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    12
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 Started
Mar 01
2021
Anticipated
Primary Completion
Dec 01
2021
Anticipated
Study Completion
Jun 14
2022
Anticipated
Last Update
Jan 13
2021

Biological Umbilical Cord Blood Plasma

Intravenous Infusion of Umbilical Cord Blood Plasma

Umbilical Cord Plasma Infusion Experimental

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

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

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No Results Posted