PROTOCOL 001.16-BMSCTI: “Phase 1/2 Clinical Study Evaluating the Safety and Efficacy of Fresh Frozen Plasma (GMFFP) from young healthy donors ages 18 to 35, who have received Granulocyte – Colony Stimulating Factor (G-CSF) to Ameliorate Frailty and Enhance the Immune Risk Profile in Older Individuals”
The primary purpose of this study is to determine the safety and tolerability of 12, once monthly transfusions of Granulocyte – Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma (GMFFP) harvested from young, healthy donors and 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. The secondary objective is 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.