Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Umbilical Cord Blood Transplant |
Biological: Umbilical Cord Blood (UCB) Units |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 250 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Claudio Brunstein, MD 612-625-3918 bruns072@umn.edu | |
| Principal Investigator: Claudio Brunstein, MD | |
| Principal Investigator: | Claudio Brunstein, MD | Masonic Cancer Center, University of Minnesota |
More Information
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01451502 History of Changes |
| Other Study ID Numbers: | 2011LS079, MT2011-13R |
| Study First Received: | October 11, 2011 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 16, 2013