Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in … (NCT03458429) | Clinical Trial Compass
By InvitationPhase 1/2
Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals
United States30 participantsStarted 2018-02-05
Plain-language summary
1. Primary Objective
To determine the safety and tolerability of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), given to older, frail individuals who are at risk due to unhealthy aging and who will then have a subsequent 12-month follow-up period.
2. Secondary Objective
To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve the Immune Risk Profile, ("IRP"), cognitive function (MME), quality of life (OPQOL-35), Frailty Index ("FI"), associated with unhealthy aging in the treated subjects.
Who can participate
Age range55 Years – 95 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent.
* Be aged between 55-95 years.
* Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a score of 4-7 on the Clinical Frailty Scale (Appendix 1) and/or Have an abnormal Immune Risk Profile (IRP)
* Not be pregnant or nursing while participating in this trial. Both men and women of reproductive potential must agree to use an effective means of birth control while participating in the trial. Women of childbearing potential should have a negative serum pregnancy test before treatment, if not surgically sterile.
* Have a negative neutrophil antibody test.
* Have a negative Human Leukocyte Antigen (HLA) Class I and II antibody test.
* Have Cytomegalovirus (CMV) negative or positive sero-testing completed.
* Have a life expectancy of at least 24 months as judged by the PI at the time of consent.
* Have less than 4 weeks since prior medical therapy, radiation therapy, and/or surgery
* Have adequate organ function including:
Hemoglobin greater than 10.0 g/dl Absolute neutrophils must be greater than 1,500/Microliter(uL) Platelet count must be greater than100,000/uL Serum bilirubin must be less than 2mg/dL Aspartate Aminotransferase (AST) must be less than 90 units/L Alanine Transaminase (ALT) must be less than 105 units/L Serum creatinine must be less than 2mg/dL
Exclusion Criteria:
* Have a score of less than 4 or greater than 7 on the Clinical Frailty Scale or Have a score of less tha…
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events