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NCT Number: NCT01451502

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

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.

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Key information

Conditions

Lymphatic Diseases Hematologic Diseases Hematologic Neoplasms Hematopoietic Malignancy Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Claudio Brunstein, MD

CONTACT

[email protected]

612-625-3918

Claudio Brunstein, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.

    Time frame: 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.

Secondary outcomes

  1. Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units

    Time frame: Up to Day 180

    point estimations and 95% confidence intervals of serious infusion reaction

  2. Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units

    Time frame: Prior to Infusion

    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).

  3. Incidence of Mislabeled UCB Units

    Time frame: Up to Day 180

    Point estimations and 95% confidence intervals of incidences mislabeled UCB units

  4. Comparison of Specific Cord Blood Banks (CBBs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2011
Primary completion
2026
Study completion
2027
First posted
Oct 13, 2011
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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