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

American Academy of Regenerative Medicine

Status and phase: Unknown; Phase 1

Conditions: Age-related Cognitive Decline

Treatments: Biological: Umbilical Cord Blood Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04566757

AARM2020

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Umbilical Cord Plasma Infusion

Experimental group

Description:

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

Treatment:

Biological: Umbilical Cord Blood Plasma