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

Age-related Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04566757
• Other study ID #: AARM2020
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: June 14, 2022

Study information

• Verified date: January 2021
• Source: American Academy of Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: June 14, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

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Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Biological:
• Umbilical Cord Blood Plasma
Intravenous Infusion of Umbilical Cord Blood Plasma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American Academy of Regenerative Medicine

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Umbilical Cord Blood Plasma Infusion	Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion	6 months
Secondary	Assessment of Executive Function	Assessment of executive function by Wisconsin Card Sorting Test (WCST)	12 months
Secondary	Assessment of Working Memory	Assessment of working memory by Wechsler Memory Scale	12 months