Clinical trial NCT01451502: Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Official title: Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphatic Diseases
Hematopoietic Malignancy
Keywords: umbilical cord blood
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

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 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 criteria: 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.

Primary outcomes:
measure: Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
timeFrame: Within 24 Hours Post Infusion
Secondary outcomes:
measure: Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
timeFrame: Up to Day 180
measure: Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units
timeFrame: Prior to Infusion
measure: Incidence of Mislabeled UCB Units
timeFrame: Up to Day 180
measure: Comparison of Specific Cord Blood Banks (CBBs)
timeFrame: Up to Day 180
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: John Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: