Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning.
Subject (or parent/guardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells
Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank
Disqualifiers
Exclusion criteria are specified in the treatment protocol according to indication.
Trial design
Design model
Single group
Treatments tested in this trial
Umbilical Cord Blood (UCB)
Biological/VaccineInfusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Unlicensed Umbilical Cord Blood InfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 InfusionSecondary outcomes
1
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 1802
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 Infusion3
Incidence of Mislabeled UCB Units
Point estimations and 95% confidence intervals of incidences mislabeled UCB units
Time frame
Up to Day 1804
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 180Sponsors and contacts
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Source ClinicalTrials.gov