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Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Open (Enrolling)
Umbilical Cord Blood Transplant

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Trial Information

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.

Outcome Description:

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.

Outcome Time Frame:

Within 24 Hours Post Infusion

Safety Issue:


Principal Investigator

Claudio Brunstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

December 2015

Related Keywords:

  • Umbilical Cord Blood Transplant



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455