Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Exclusion criteria are specified in the treatment protocol according to indication.
研究组 & 干预措施
Unlicensed Umbilical Cord Blood Infusion
All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.
-
Pre-infusion treatment using intravenous hydration, acetaminophen and diphenhydramine hydrochloride
-
Unlicensed Umbilical Cord Blood Infusion according to institutional guidelines.
-
Infusion of minimally manipulated unlicensed UCB units:
-
vital signs Monitoring during and after UCB infusion:
-
Management of infusion reactions
-
Post-transplant care and follow-up: will be done according to the disease specific treatment protocol and institutional guidelines.
干预措施: Umbilical Cord Blood (UCB) (Biological)
结局指标
主要结局
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
时间窗: 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.
次要结局
- Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units(Up to Day 180)
- Incidence of Mislabeled UCB Units(Up to Day 180)
- Comparison of Specific Cord Blood Banks (CBBs)(Up to Day 180)
- Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units(Prior to Infusion)