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Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

NCT ID: NCT01451502

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Lymphatic Diseases Hematopoietic Malignancy

Keywords

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umbilical cord blood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Umbilical Cord Blood (UCB)

Intervention Type BIOLOGICAL

Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Interventions

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Umbilical Cord Blood (UCB)

Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Hoover, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

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Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Claudio Brunstein, MD

Role: primary

Other Identifiers

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MT2011-13R

Identifier Type: OTHER

Identifier Source: secondary_id

2011LS079

Identifier Type: -

Identifier Source: org_study_id