An interventional study of Umbilical Cord Blood (UCB) in Lymphatic Diseases and Hematopoietic Malignancy, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Other
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.
47 studies on the registry are indexed under Lymphatic Diseases; 11 are open to participants now.
This study's planned enrollment of 250 is above the median of 30 across 31 interventional studies indexed under Lymphatic Diseases.
Browse Lymphatic Diseases studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below:
Exclusion Criteria:
All patients will be registered in OnCore under this protocol as well as the specific treatment protocol. * Pre-infusion treatment using intravenous hydration, acetaminophen and diphenhydramine hydrochloride * Unlicensed Umbilical Cord Blood Infusion according to institutional guidelines. * Infusion of minimally manipulated unlicensed UCB units: * vital signs Monitoring during and after UCB infusion: * Management of infusion reactions * Post-transplant care and follow-up: will be done according to the disease specific treatment protocol and institutional guidelines.
Biological: Umbilical Cord Blood (UCB)
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
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.
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Masonic Cancer Center, University of Minnesota