Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

NCT01451502 | Recruiting

• 2 other identifiers: 2011LS079MT2011-13R
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphatic Diseases; Hematopoietic Malignancy

Keywords

umbilical cord blood

Outcome Measures

Primary Outcomes (1)

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

  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.

  Within 24 Hours Post Infusion

Secondary Outcomes (4)

• Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units

  Up to Day 180

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

  Prior to Infusion

• Incidence of Mislabeled UCB Units

  Up to Day 180

• Comparison of Specific Cord Blood Banks (CBBs)

  Up to Day 180

Study Arms (1)

Unlicensed Umbilical Cord Blood Infusion

EXPERIMENTAL

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.

Biological: Umbilical Cord Blood (UCB)

Interventions

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.

Unlicensed Umbilical Cord Blood Infusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Lymphatic Diseases; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases

Study Officials

• Alex Hoover, MD, MSc

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 13, 2011
• Study Start: October 20, 2011
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)