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Trial record 2 of 733 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Recruitment Status : Withdrawn (Protocol required revisions and application was withdrawn from the IRB.)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

Tracking Information
First Submitted Date  ICMJE January 13, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date May 22, 2020
Estimated Study Start Date  ICMJE May 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • 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%
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults
Official Title  ICMJE 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
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Frailty Syndrome
  • Heart Failure
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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).

    Intervention: Biological: Allogeneic Young Plasma
  • 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).

    Intervention: Biological: Allogeneic Young Plasma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
3
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241159
Other Study ID Numbers  ICMJE IRB00061606
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shawn Johnson, D.O.., M.S. Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP