Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units|
- Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [ Time Frame: Within 24 Hours Post Infusion ] [ Designated as safety issue: Yes ]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.
- Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]
- Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units [ Time Frame: Prior to Infusion ] [ Designated as safety issue: Yes ]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 [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]
- Comparison of Specific Cord Blood Banks (CBBs) [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Patients Receiving Unlicensed Umbilical Cord Blood Units
All patients will be registered in OnCore under this protocol as well as the specific treatment protocol. Included in the registration for this study will be the name of the Cord Blood Bank from which the unlicensed UCB unit was obtained.
Biological: Umbilical Cord Blood (UCB) Units
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
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.
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Claudio Brunstein, MD 612-625-3918 email@example.com|
|Principal Investigator: Claudio Brunstein, MD|
|Principal Investigator:||Claudio Brunstein, MD||Masonic Cancer Center, University of Minnesota|