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RECRUITING Not applicable ClinicalTrials.gov

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Sponsor: Masonic Cancer Center, University of Minnesota • ClinicalTrials.gov ID: NCT01451502

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Umbilical Cord Blood (UCB) (Biological)
    Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Eligibility criteria

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.

Conditions

Lymphatic Diseases Hematopoietic Malignancy

Locations

  • Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record