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

• Status: Enrolling by invitation
• Trial end date: 2023-02-26

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.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Dipnarine Maharaj
• Treatments: Lenograstim; Sargramostim