Infusión de poblaciones celulares de unidades de sangre de cordón umbilical sin licencia
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- Masonic Cancer Center, University of Minnesota
-
Contacto:
- Claudio Brunstein, MD
- Número de teléfono: 612-625-3918
- Correo electrónico: bruns072@umn.edu
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Investigador principal:
- Claudio Brunstein, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Unlicensed Umbilical Cord Blood Infusion
All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.
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Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
Periodo de tiempo: 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. |
Within 24 Hours Post Infusion
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
Periodo de tiempo: Up to Day 180
|
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
Periodo de tiempo: Prior to Infusion
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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
Periodo de tiempo: Up to Day 180
|
Point estimations and 95% confidence intervals of incidences mislabeled UCB units |
Up to Day 180
|
|
Comparison of Specific Cord Blood Banks (CBBs)
Periodo de tiempo: 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. |
Up to Day 180
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alex Hoover, MD, MSc, Masonic Cancer Center, University of Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2011LS079
- MT2011-13R (Otro identificador: Blood and Marrow Transplantation Program)
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