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

May 21, 2020 updated by: Wake Forest University Health Sciences

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 76 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • PF24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post 5 weeks after the last infusion of plasma

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
Post 5 weeks after the last infusion of plasma
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
Study endpoint weeks 11 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Shawn Johnson, D.O.., M.S., Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00061606

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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