Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Study Overview
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Brief Summary
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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
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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.

Official Title
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Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Conditions
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Lymphatic Diseases, Hematopoietic Malignancy

Intervention / Treatment
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* Biological: Umbilical Cord Blood (UCB)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unlicensed Umbilical Cord Blood Infusion<br>All patients will be registered in OnCore under this protocol as well as the specific treatment protocol. Pre-infusion treatment using intravenous hydration, acetaminophen and diphenhydramine hydrochloride Unlicensed Umbilical Cord Blood Infusion according to institutional guidelines. Infusion of minimally manipulated unlicensed UCB units: vital signs Monitoring during and after UCB infusion: Management of infusion reactions Post-transplant care and follow-up: will be done according to the disease specific treatment protocol and institutional guidelines. | Biological: Umbilical Cord Blood (UCB)<br>* Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. | 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. | Within 24 Hours Post Infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units | point estimations and 95% confidence intervals of serious infusion reaction | Up to Day 180 | 
| Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units | Upon thawing (e.g., number of CD34 and colony forming cells for hematopoietic products or number of CD4+/CD25+/CD127- cells for Treg products prior to further manipulation). | Prior to Infusion | 
| Incidence of Mislabeled UCB Units | Point estimations and 95% confidence intervals of incidences mislabeled UCB units | Up to Day 180 | 
| Comparison of Specific Cord Blood Banks (CBBs) | Determine if bacterial contamination, poor cell recoveries, shipment of mislabeled units, blood borne pathogen transmission or serious infusion reactions are more prevalent in units from specific CBBs. | Up to Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord blood