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Trial record 2 of 729 for:    young plasma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241159
Recruitment Status : Withdrawn (Protocol required revisions and application was withdrawn from the IRB.)
First Posted : January 27, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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

Condition or disease Intervention/treatment Phase
Frailty Syndrome Heart Failure Biological: Allogeneic Young Plasma Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Geriatric participants with frailty

Geriatric 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).

Biological: Allogeneic Young Plasma

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.

Other Name: PF24

Experimental: Geriatric participants with HFpEF

Geriatric 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).

Biological: Allogeneic Young Plasma

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.

Other Name: PF24




Primary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: Post 5 weeks after the last infusion of plasma ]
    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.


Secondary Outcome Measures :
  1. Study participant retention [ Time Frame: Post 5 weeks after the last infusion of plasma ]
    Secondary outcomes include indicators of feasibility as assessed by measuring study participant retention >/= 80%

  2. Study participants ability to complete the Fried Frailty Assessment [ Time Frame: Study endpoint weeks 11 and 15 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241159


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Shawn Johnson, D.O.., M.S. Wake Forest University Health Sciences
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.
Bilder, G., Human biological aging : from macromolecules to organ-systems. 2016, Hoboken, New Jersey: Wiley Blackwell. ix, 330 pages.
Savarese, D. Common Terminology Criteria for Adverse Events. 2019 [cited 2019 2019]; Available from: https://www.uptodate.com/contents/common-terminology-criteria-for-adverse-events?search=Common%20Terminology%20Criteria%20for%20Adverse%20Events.&source=search_result&selectedTitle=1~38&usage_type=default&display_rank=1
Silvergleid, A.J. Clinical Use of Plasma Components. [cited 2019]/ Available from: https://www.uptodate.com/contents/clinical-use-of-plasma-components
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA). Available from: https://clinicaltrials.gov/ct2/show/NCT02256306?term=PLASMA&rank=1
Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects (RESET-YOUTH). Available from: https://clinicaltrials.gov/ct2/show/NCT03353597?term=Reset-YOuth&rank=1
Fresh Frozen Plasma: Indications and Risks: NIH Consensus Development Conference Statement. 1984 9/11/2018]; Available from: https://consensus.nih.gov/1984/1984FrozenPlasma045html.htm.
Silvergleid, A.J. Approach to the patient with a suspected acute transfusion reaction. 4/23/18]; Available from: https://www.uptodate.com/contents/approach-to-the-patient-with-a-suspected-acute-transfusion-reaction
Diane, S. Common Terminology Criteria for Adverse Events. April 23, 2018; Available from: http://www.uptodate.com

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04241159    
Other Study ID Numbers: IRB00061606
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Frailty
Aging
Heart failure
Plasma
Infusion
Additional relevant MeSH terms:
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Heart Failure
Syndrome
Frailty
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases