Overview

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

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.