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

• Sponsor: American Academy of Regenerative Medicine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04566757
• Collaborator: (none)
• Enrollment: 12
• Arm: 1
• Anticipated Duration (Months): 15.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Cognitive Decline	Biological: Umbilical Cord Blood Plasma	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Jun 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Umbilical Cord Plasma Infusion Infusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months	Biological: Umbilical Cord Blood Plasma; Intravenous Infusion of Umbilical Cord Blood Plasma

Outcome Measures

Primary Outcome Measures

1. 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

1. Assessment of Executive Function [12 months]

   Assessment of executive function by Wisconsin Card Sorting Test (WCST)

2. Assessment of Working Memory [12 months]

   Assessment of working memory by Wechsler Memory Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• American Academy of Regenerative Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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. Review.
• 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-Després 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.
• 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.

• Responsible Party: American Academy of Regenerative Medicine
• ClinicalTrials.gov Identifier: NCT04566757
• Other Study ID Numbers: AARM2020
• First Posted: Sep 28, 2020
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Jan 13, 2021