Back to resultsInfusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Primary Purpose
Lymphatic Diseases, Hematopoietic Malignancy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Umbilical Cord Blood (UCB)
Sponsored by
About this trial
This is an interventional other trial for Lymphatic Diseases focused on measuring umbilical cord blood
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.
Sites / Locations
- Masonic Cancer Center, University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Unlicensed Umbilical Cord Blood Infusion
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
point estimations and 95% confidence intervals of serious infusion reaction
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).
Incidence of Mislabeled UCB Units
Point estimations and 95% confidence intervals of incidences mislabeled UCB units
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.
Full Information
NCT ID
NCT01451502
First Posted
October 11, 2011
Last Updated
January 25, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01451502
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2011 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Diseases, Hematopoietic Malignancy
Keywords
umbilical cord blood
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unlicensed Umbilical Cord Blood Infusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood (UCB)
Intervention Description
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
Primary Outcome Measure Information:
Title
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
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.
Time Frame
Within 24 Hours Post Infusion
Secondary Outcome Measure Information:
Title
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
Description
point estimations and 95% confidence intervals of serious infusion reaction
Time Frame
Up to Day 180
Title
Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units
Description
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).
Time Frame
Prior to Infusion
Title
Incidence of Mislabeled UCB Units
Description
Point estimations and 95% confidence intervals of incidences mislabeled UCB units
Time Frame
Up to Day 180
Title
Comparison of Specific Cord Blood Banks (CBBs)
Description
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.
Time Frame
Up to Day 180
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Wagner, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Brunstein, MD
Phone
612-625-3918
Email
bruns072@umn.edu
First Name & Middle Initial & Last Name & Degree
Claudio Brunstein, MD
12. IPD Sharing Statement
Learn more about this trial
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
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