Status:
RECRUITING
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Lymphatic Diseases
Hematopoietic Malignancy
Eligibility:
All Genders
Phase:
NA
Brief 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 Adm...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- Exclusion criteria are specified in the treatment protocol according to indication.
Key Trial Info
Start Date :
October 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01451502
Start Date
October 20 2011
End Date
December 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455