For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
250
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGIncidence 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.
Time frame: Within 24 Hours Post Infusion
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
point estimations and 95% confidence intervals of serious infusion reaction
Time frame: Up to Day 180
Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units
Upon thawing (e.g., number of CD34 and colony forming cells for hematopoietic products or number of CD4+/CD25+/CD127- cells for Treg products prior to further manipulation).
Time frame: Prior to Infusion
Incidence of Mislabeled UCB Units
Point estimations and 95% confidence intervals of incidences mislabeled UCB units
Time frame: Up to Day 180
Comparison of Specific Cord Blood Banks (CBBs)
Determine if bacterial contamination, poor cell recoveries, shipment of mislabeled units, blood borne pathogen transmission or serious infusion reactions are more prevalent in units from specific CBBs.
Time frame: Up to Day 180
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