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Frailty SyndromeEarly Phase 1NCT04241159

Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults

A Early Phase 1 study testing Allogeneic Young Plasma in people with Frailty Syndrome and Heart Failure, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Evaluate the feasibility of administering plasma (PF24) acquired from donors of a young chronological age intravenously to older adults at WFBMC while also exploring its effects on age-related functional decline Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Frailty Syndrome, Heart Failure
What is being tested?
Allogeneic Young Plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2020to Aug 2020
Phase
Early 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 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • English speaking elderly males and females, aged 65-80 years, referred by the Gerontology Department and the Cardiology Clinic of the Wake Forest Baptist Health Sticht Center for Aging.
  • a score of 3 or greater (at least frail status) as demonstrated by the Fried Frailty criteria.

Who cannot join

  • Unable or unwilling to give informed consent in either study group
  • Current psychiatric disorder not currently under control or being adequately treated
  • Current consumption of more than 14 alcoholic drinks per week
  • Self-reported inability to walk across a small room
  • Residence in a nursing home
  • Previous MOCA score below 21
Show all 43Show fewer
  • Difficulty in communication with study personnel due to speech or hearing problems
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
  • Elective surgery, planned prior to signing consent
  • Severe osteoarthritis
  • Rheumatoid arthritis
  • Severe B/L hip, knee, or hand pain (>7/10 on pain scale)
  • Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
  • Pulmonary disease including VQ mismatch/diffusion limitation, diminished inspired O2, hypoventilation, pulmonary fibrosis, or sarcoidosis
  • Current tobacco use (smoke/chew)
  • Currently prescribed corticosteroids
  • Patients taking nucleoside analogues (Zebularine, 5-azaC, Decitabine)
  • Patients on non-nucleoside analogues (Procaine, procainamide, hydralazine)
  • History of an inherited bleeding disorder or vitamin K deficiency
  • Cardiovascular disease (excluding HFpEF), clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator or uncontrolled angina.
  • Parkinson's disease or other serious neurological disorder
  • MMS score < 18
  • Renal disease (any stage, inappropriate for age; Cr Cl < 60)
  • Hypoalbuminemia, with serum albumin level < 3.5 g/dL
  • History of IgA deficiency
  • History of hypersensitivity to frozen plasma (PF24) or to plasma-derived products including any plasma protein
  • Active hepatitis or history of liver transplant
  • Anemia or polycythemia: Male - Hgb level below 12 or above 17.5 g/dL and/or HCT of 41%-53%. Female: Hgb level below 10.0 or above 16.0 g/dL and/or HCT 36%-46%
  • Current use of anti-coagulants
  • History of DMI or DMII
  • Peripheral vascular disease
  • Brain aneurysm or intracranial hemorrhage within the past 6 months
  • History of Hepatitis B, Hepatitis C, or HIV infection
  • Other illness of such severity that life expectancy is considered to be less than 12 months
  • Patients with initial VO2max that falls below expected value or that does not meet a minimum VO2max of 20 mL * kg * min (in order to demonstrate a more clinically meaningful increase)
  • Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg)
  • CVA, hip fracture, B/L hip or knee replacement, or spinal surgery in the past 6 months
  • Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG
  • Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolism in the past 6 months
  • Undergoing physical therapy or cardiopulmonary rehabilitation
  • Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
  • Currently on an anaerobic/aerobic exercise plan
  • Inability or unwillingness to return for all transfusions/FU visits

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Small-Scale Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults Experiencing Disability Across the Spectrum of Frailty Syndrome

Evaluate the feasibility of administering plasma (PF24) acquired from donors of a young chronological age intravenously to older adults at WFBMC while also exploring its effects on age-related functional decline

Read the detailed description

A Small-Scale Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults Experiencing Disability Across the Spectrum of Frailty Syndrome

Plasma (PF24) will be transfused into enrolled male and female geriatric patients aged 65-80 who have a diagnosis of frailty (Fried Frailty score of 3 or greater) or HFpEF. The experimental dosing will consist of once weekly administration of PF24 over a period of 8 consecutive weeks (8 total doses over 56 days). Primary and secondary endpoints will measure safety and feasibility of infusing PF24 in this study population. Tertiary endpoints will include measurement of the Fried Frailty score, various cognitive testing, measurement of VO2max, and blood biomarkers associated with aging. We will measure change from baseline 1 week after the 8th infusion of PF24. Test of durability will occur 5 weeks after the 8th infusion of plasma.

Being tested
Allogeneic Young Plasma
Keywords
Frailty, Aging, Heart failure, Plasma, Infusion
Medical subject headings
Frailty, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic Young PlasmaBiological

    Also called PF24

    The experimental dosing will consist of once weekly administration of PF24 over a period of 8 consecutive weeks (8 total doses over 56 days). 250 mL single units of PF24 will be obtained from the South Texas Blood Bank and processed by the WFBH Blood Bank.

    1 unit (250 mL) PF24, will be infused at 1 mL/kg/hr, once weekly for 8 consecutive weeks.

Study groups in NCT04241159
Study groupRoleWhat they receive
Geriatric participants with frailtyExperimentalGeriatric participants aged 65-80 who have a diagnosis of frailty (Fried Frailty score of 3 or greater). Experimental dosing will consist of once weekly administration of PF24 over a period of 8 consecutive weeks (8 total doses over 56 days).
Receives: Biological: Allogeneic Young Plasma
Geriatric participants with HFpEFExperimentalGeriatric participants aged 65-80 who have a diagnosis of HFpEF. Experimental dosing will consist of once weekly administration of PF24 over a period of 8 consecutive weeks (8 total doses over 56 days).
Receives: Biological: Allogeneic Young Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events

    The primary outcomes of this phase 0 study are built upon evaluating the outcome of safety with administering plasma (PF24) acquired from donors of a young chronological age intravenously to older adults at WFBMC, as evidenced by lack of any grade 4-5 adverse events and >/=50% grade 3-4 adverse events, as defined by NCI CTCAE v5.0. Grade 1-2 events will be recorded for statistical purposes.

    Measured: Post 5 weeks after the last infusion of plasma

Secondary outcomes (2)

  1. Study participant retention

    Secondary outcomes include indicators of feasibility as assessed by measuring study participant retention >/= 80%

    Measured: Post 5 weeks after the last infusion of plasma

  2. Study participants ability to complete the Fried Frailty Assessment

    Measurement of the Fried Frailty Score - The stages of frailty based on the Fried Frailty assessment criteria: a score of 0 means that a person is robust or not frail. Persons with a score of 1 or 2 are at intermediate risk for adverse outcomes or are considered to be pre-frail. A score of 3-5 indicates that someone is frail

    Measured: Study endpoint weeks 11 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study startMay 2020 (estimated)
  3. Primary completionAug 2020 (estimated)
  4. Study completionAug 2020 (estimated)

Why it stopped: Protocol required revisions and application was withdrawn from the IRB.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
All eligible study participants will undergo once weekly PF24 infusion for 8 weeks in the WFBH Clinical Research Unit (CRU), and return for cognitive, physical, and biomarker testing 1 week and 5 weeks after receiving the last dose of PF24.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04241159
Sponsor's protocol ID
IRB00061606
Status last verified
Nov 2019
First submitted
13 Jan 2020
Last updated
22 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Aging Well in the 21st Century: Strategic Directions for Research on Aging. [cited 2018 8/10/18]; Available from: https://www.nia.nih.gov/about/aging-well-21st-century-strategic-directions-research-aging.

  • Olivieri F, Capri M, Bonafe M, Morsiani C, Jung HJ, Spazzafumo L, Vina J, Suh Y. Circulating miRNAs and miRNA shuttles as biomarkers: Perspective trajectories of healthy and unhealthy aging. Mech Ageing Dev. 2017 Jul;165(Pt B):162-170. doi: 10.1016/j.mad.2016.12.004. Epub 2016 Dec 13.

    PubMed 27986629

  • Hayflick L. Biological aging is no longer an unsolved problem. Ann N Y Acad Sci. 2007 Apr;1100:1-13. doi: 10.1196/annals.1395.001.

    PubMed 17460161

  • Bilder, G., Human biological aging : from macromolecules to organ-systems. 2016, Hoboken, New Jersey: Wiley Blackwell. ix, 330 pages.

  • Hatse S, Brouwers B, Dalmasso B, Laenen A, Kenis C, Schoffski P, Wildiers H. Circulating MicroRNAs as easy-to-measure aging biomarkers in older breast cancer patients: correlation with chronological age but not with fitness/frailty status. PLoS One. 2014 Oct 21;9(10):e110644. doi: 10.1371/journal.pone.0110644. eCollection 2014.

    PubMed 25333486

  • Kadota T, Fujita Y, Yoshioka Y, Araya J, Kuwano K, Ochiya T. Emerging role of extracellular vesicles as a senescence-associated secretory phenotype: Insights into the pathophysiology of lung diseases. Mol Aspects Med. 2018 Apr;60:92-103. doi: 10.1016/j.mam.2017.11.005. Epub 2017 Nov 20.

    PubMed 29146100

  • Sinha M, Jang YC, Oh J, Khong D, Wu EY, Manohar R, Miller C, Regalado SG, Loffredo FS, Pancoast JR, Hirshman MF, Lebowitz J, Shadrach JL, Cerletti M, Kim MJ, Serwold T, Goodyear LJ, Rosner B, Lee RT, Wagers AJ. Restoring systemic GDF11 levels reverses age-related dysfunction in mouse skeletal muscle. Science. 2014 May 9;344(6184):649-52. doi: 10.1126/science.1251152. Epub 2014 May 5.

    PubMed 24797481

  • Loffredo FS, Steinhauser ML, Jay SM, Gannon J, Pancoast JR, Yalamanchi P, Sinha M, Dall'Osso C, Khong D, Shadrach JL, Miller CM, Singer BS, Stewart A, Psychogios N, Gerszten RE, Hartigan AJ, Kim MJ, Serwold T, Wagers AJ, Lee RT. Growth differentiation factor 11 is a circulating factor that reverses age-related cardiac hypertrophy. Cell. 2013 May 9;153(4):828-39. doi: 10.1016/j.cell.2013.04.015.

    PubMed 23663781

  • Middeldorp J, Lehallier B, Villeda SA, Miedema SS, Evans E, Czirr E, Zhang H, Luo J, Stan T, Mosher KI, Masliah E, Wyss-Coray T. Preclinical Assessment of Young Blood Plasma for Alzheimer Disease. JAMA Neurol. 2016 Nov 1;73(11):1325-1333. doi: 10.1001/jamaneurol.2016.3185.

    PubMed 27598869

  • Katsimpardi L, Litterman NK, Schein PA, Miller CM, Loffredo FS, Wojtkiewicz GR, Chen JW, Lee RT, Wagers AJ, Rubin LL. Vascular and neurogenic rejuvenation of the aging mouse brain by young systemic factors. Science. 2014 May 9;344(6184):630-4. doi: 10.1126/science.1251141. Epub 2014 May 5.

    PubMed 24797482

  • Upadhya B, Pisani B, Kitzman DW. Evolution of a Geriatric Syndrome: Pathophysiology and Treatment of Heart Failure with Preserved Ejection Fraction. J Am Geriatr Soc. 2017 Nov;65(11):2431-2440. doi: 10.1111/jgs.15141.

    PubMed 29124734

  • Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW. Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11.

    PubMed 30007558

  • Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50. doi: 10.1001/jama.288.17.2144.

    PubMed 12413374

  • Haykowsky MJ, Tomczak CR, Scott JM, Paterson DI, Kitzman DW. Determinants of exercise intolerance in patients with heart failure and reduced or preserved ejection fraction. J Appl Physiol (1985). 2015 Sep 15;119(6):739-44. doi: 10.1152/japplphysiol.00049.2015. Epub 2015 Apr 24.

    PubMed 25911681

  • Stehle JR Jr, Leng X, Kitzman DW, Nicklas BJ, Kritchevsky SB, High KP. Lipopolysaccharide-binding protein, a surrogate marker of microbial translocation, is associated with physical function in healthy older adults. J Gerontol A Biol Sci Med Sci. 2012 Nov;67(11):1212-8. doi: 10.1093/gerona/gls178. Epub 2012 Sep 7.

    PubMed 22960476

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Allogeneic Young Plasma in people with Frailty Syndrome and Heart Failure, run by Wake Forest University Health Sciences at 1 site in United States.

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 2 inclusion and 43 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: withdrawn, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Frequency of adverse events (time frame: Post 5 weeks after the last infusion of plasma). 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 NCT04241159, which also lists 32 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 22 May 2020.

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