Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
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|ClinicalTrials.gov Identifier: NCT01451502|
Recruitment Status : Recruiting
First Posted : October 13, 2011
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphatic Diseases Hematopoietic Malignancy||Biological: Umbilical Cord Blood (UCB)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units|
|Actual Study Start Date :||October 20, 2011|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Unlicensed Umbilical Cord Blood Infusion
All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.
Biological: Umbilical Cord Blood (UCB)
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
- Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [ Time Frame: Within 24 Hours Post Infusion ]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 ]
- Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units [ Time Frame: Prior to Infusion ]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 ]
- Comparison of Specific Cord Blood Banks (CBBs) [ Time Frame: Up to Day 180 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451502
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Claudio Brunstein, MD 612-625-3918 firstname.lastname@example.org|
|Principal Investigator: Claudio Brunstein, MD|
|Principal Investigator:||Claudio Brunstein, MD||Masonic Cancer Center, University of Minnesota|