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Recruiting NCT01451502

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

No phase Interventional Lymphatic Diseases Hematopoietic Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Umbilical Cord Blood (UCB).
Who it may be relevant to
Registry conditions: Lymphatic Diseases, Hematopoietic Malignancy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [Time frame: Within 24 Hours Post Infusion]
Secondary outcome measures (4)
  • Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units [Time frame: Up to Day 180]
  • Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units [Time frame: Prior to Infusion]
  • Incidence of Mislabeled UCB Units [Time frame: Up to Day 180]
  • Comparison of Specific Cord Blood Banks (CBBs) [Time frame: Up to Day 180]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Masonic Cancer Center, University of Minnesota — Minneapolis

Identifiers

NCT: NCT01451502 · 2011LS079 · MT2011-13R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗