Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Masonic Cancer Center, University of Minnesota
250 participants
Oct 20, 2011
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
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Interventions
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
Locations(1)
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NCT01451502