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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04566757

Enrollment

Registered

2020-09-28

Start date

2021-03-01

Completion date

2022-06-14

Last updated

2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cognitive Decline

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.

Interventions

BIOLOGICALUmbilical Cord Blood Plasma

Intravenous Infusion of Umbilical Cord Blood Plasma

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026