Идёт набор NCT01451502

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Без фазы С лечением Lymphatic Diseases Hematopoietic Malignancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Umbilical Cord Blood (UCB).
Кому может быть актуально: Состояния в реестре: Lymphatic Diseases, Hematopoietic Malignancy. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Биопрепарат Umbilical Cord Blood (UCB)
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Первичные конечные точки

Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [Срок оценки: Within 24 Hours Post Infusion]

Вторичные конечные точки (4)

Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units [Срок оценки: Up to Day 180]
Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units [Срок оценки: Prior to Infusion]
Incidence of Mislabeled UCB Units [Срок оценки: Up to Day 180]
Comparison of Specific Cord Blood Banks (CBBs) [Срок оценки: Up to Day 180]

Критерии участия

Критерии включения

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