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

Phase 1

• Conditions: Age-related Cognitive Decline
• Interventions: Biological: Umbilical Cord Blood Plasma

• Registration Number: NCT04566757
• Lead Sponsor: American Academy of Regenerative Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13
• Study Start: 2021-03-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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