drugset
drugset / Trial / NCT03458429

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

NCT03458429 ↗

Phase 1/2 Enrolling by invitation 30 enrolled Dipnarine Maharaj
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-02-05
Primary completion
2029-12-30
Completion
2030-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject GMFFP Unknown — —

Indications

No indication recorded.