Clinical trial NCT04566757: Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
Official title: Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Age-related Cognitive Decline
Lead sponsor: American Academy of Regenerative Medicine
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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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Primary outcomes:
measure: Safety of Umbilical Cord Blood Plasma Infusion
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of Executive Function
timeFrame: 12 months
measure: Assessment of Working Memory
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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-Despres 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.
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.
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.