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RecruitingInterventional

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

NCT ID: NCT01451502Sponsor: Masonic Cancer Center, University of MinnesotaLast updated: 2026-05-08

Summary

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.

Detailed description

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.

Arms & interventions

  • BiologicalUmbilical Cord Blood (UCB)

    Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Outcome measures

Primary

  • 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

Secondary

  • Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units

    Time frame: Up to Day 180

  • Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units

    Time frame: Prior to Infusion

  • Incidence of Mislabeled UCB Units

    Time frame: Up to Day 180

  • Comparison of Specific Cord Blood Banks (CBBs)

    Time frame: Up to Day 180

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: No
Inclusion Criteria: To be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below: * 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 Exclusion Criteria: * Exclusion criteria are specified in the treatment protocol according to indication.

Study locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455

Recruiting
Claudio Brunstein, MD · Contact
612-625-3918bruns072@umn.edu
Claudio Brunstein, MD · Principal Investigator