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| ID | Type | Description | Link |
|---|---|---|---|
| MT2011-13R | Other Identifier | Blood and Marrow Transplantation Program |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unlicensed Umbilical Cord Blood Infusion | Experimental | All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Blood (UCB) | Biological | Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Hoover, MD, MSc | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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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 |