Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Masonic Cancer Center, University of Minnesota
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.
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy 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…
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.
Location
- Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota