Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals

Exclusion Criteria

• •Have a score of less than 4 or greater than 7 on the Clinical Frailty Scale or Have a score of less than 4 and a No Immune Risk Profile (IRP)
• •Have used anti-inflammatory medications within 7 days of study treatment,treated subjects may be re-screened after 14 days
• •Abnormal clinical values including but not limited to:
• •Platelet count less than 100,000/mm3 Absolute neutrophils less than 1500/uL Hemoglobin less than 10 g/dL Aspartate transaminase, alanine transaminase, or alkaline phosphatase Greater than 3 times upper limit of normal Serum bilirubin greater than 2 mg/dL
• •Be an organ transplant recipient or have an active listing (or expected future listing) for transplant of any organ.
• •Have a documented intolerance to plasma or its components, or prior intolerance to intravenous fluids.
• •Have known serum antibodies to plasma proteins, such as haptoglobin, Complement Component (C3/C4), or alpha-1-antitrypsin.
• •Previous plasma transfusion within 30 days of signing informed consent.
• •Serious comorbid illness including, but not limited to:
• •HIV or hepatitis Congenital deficiency of immunoglobulin A (IgA) Pulmonary edema Advanced liver or renal failure Uncontrolled diabetes mellitus, Significant and/or symptomatic cardiovascular disease (e.g. any history of myocardial infarction, congestive heart failure, unstable angina, uncontrolled arrhythmia) Active serious infection. Hemorrhagic cystitis Cardiac revascularization within last six months Severe obstructive ventilatory defect Renal insufficiency (serum creatinine greater than 177 mol/L or creatinine clearance less than 20 mL/min) Sickle cell disease or hemoglobinopathy Cancer Any other condition that the investigator believes may compromise the safety or compliance of the patient or the study evaluation.
• •No vascular access
• •Pregnant or nursing female
• •Recent ( less than 24 months) history of drug or alcohol abuse
• •Current participation in an investigational therapeutic or medical device trial
• •Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial.
• •Recent use (within 30 days) of immunosuppressive agents
• •Inability to perform any assessments or relevant procedures required for the study or to give informed consent
• •Although not considered a part of the formal eligibility criteria, the treating physicians will evaluate additional factors that may increase subject risk, including but not limited to:
• •The presence of serious illnesses that would limit survival to less than two years.
• •The presence of psychiatric conditions that would prevent compliance with study visits or impact informed consent.
• •The presence of uncontrolled or severe cardiovascular disease, pulmonary disease, age-related or other serious medical conditions, or infection, which, in the opinion of the treating physician, would make study participation unreasonably hazardous.