Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Patients will receive intravenous hydration, acetaminophen and diphenhydramine hydrochloride
(or appropriate alternative regimen) approximately 30 minutes prior to UCB infusion with
doses adjusted for subject age and weight unless otherwise specified in the specific
treatment protocol. Additional treatments will vary with the specific use of the UCB cells
as specified in institutional review board (IRB)‐approved disease‐specific protocols at the
University of Minnesota.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
Documentation of events for the purpose of this study will only be for those events at least possibly related to the unlicensed UCB. Monitoring for acute infusional toxicities will end 24 hours after the umbilical cord blood (UCB) infusion.
Within 24 Hours Post Infusion
Claudio Brunstein, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|