Age-related Cognitive DeclinePhase 1NCT04566757
Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
A Phase 1 study testing Umbilical Cord Blood Plasma in people with Age-related Cognitive Decline, run by American Academy of Regenerative Medicine.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Umbilical Cord Blood Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 14 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-85 years old
- Evidence of cognitive decline on neuro-cognitive testing
- Able to participate in research trial for 12 months
- Women must have documented menopause or infertility determination
- Ability to receive intravenous infusions
- Patient or legally authorized representative able to sign informed consent
Who cannot join
- Patients receiving any other investigational biologics or drugs
- History of transfusion reaction
- Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)
- Inability to participate in cognitive or performance testing
- History of cancer in the last 5 years
- History of infectious disease within the previous 12 months
Show all 15Show fewer
- Severe kidney (eGFR< 30) and heart failure (Class III/IV)
- History of Human Immunodeficiency Virus Infection
- History of Hepatitis B, or C
- History of immunosuppressive therapy
- History of organ transplantation
- Difficulty of obtaining peripheral venous access
- Allergy to histamine blockers
- Inability to participate in the clinical trial at any data collection and end points
- -
About this study
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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Umbilical Cord Blood Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood PlasmaBiological
Intravenous Infusion of Umbilical Cord Blood Plasma
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Plasma Infusion | Experimental | Infusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months Receives: Biological: Umbilical Cord Blood Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Umbilical Cord Blood Plasma Infusion
Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion
Measured: 6 months
Secondary outcomes (2)
Assessment of Executive Function
Assessment of executive function by Wisconsin Card Sorting Test (WCST)
Measured: 12 months
Assessment of Working Memory
Assessment of working memory by Wechsler Memory Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion14 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Academy of Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566757
- Sponsor's protocol ID
- AARM2020
- Status last verified
- Jan 2021
- First submitted
- 4 Sep 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28815019Villeda 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.
PubMed 21886162Kang 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.
PubMed 32054965Villeda 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.
PubMed 24793238
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
- ClinicalTrials.gov ID
- NCT04566757
- Acronym / sponsor ID
- AARM2020
- Conditions
- Age-related Cognitive Decline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- American Academy of Regenerative MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 14 Jun 2022 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Plasma Infusion | Experimental | Biological: Umbilical Cord Blood PlasmaInfusion of 50cc of Umbilical Cord Blood Plasma bi-monthly for 6 months |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65-85 years old
- Evidence of cognitive decline on neuro-cognitive testing
- Able to participate in research trial for 12 months
- Women must have documented menopause or infertility determination
- Ability to receive intravenous infusions
Key exclusion criteria (15 listed)
- Patients receiving any other investigational biologics or drugs
- History of transfusion reaction
- Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)
- Inability to participate in cognitive or performance testing
- History of cancer in the last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Blood PlasmaIntravenous Infusion of Umbilical Cord Blood Plasma | Biological | Umbilical Cord Plasma Infusion |
Primary outcome
Safety of Umbilical Cord Blood Plasma Infusion
Time frame: 6 months
Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion
2 secondary outcomes
Assessment of Executive Function
Time frame: 12 months
Assessment of Working Memory
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 28815019Horowitz 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.
- Background: PubMed 21886162Villeda 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.
- Background: PubMed 32054965Kang 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.
- Background: PubMed 24793238Villeda 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Umbilical Cord Blood Plasma in people with Age-related Cognitive Decline, run by American Academy of Regenerative Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Umbilical Cord Blood Plasma Infusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566757, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.