Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Lymphatic Diseases Clinical Trial

Official title:

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01451502
• Other study ID #: 2011LS079
• Secondary ID: MT2011-13R
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2011
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic Malignancy
• Lymphatic Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units	point estimations and 95% confidence intervals of serious infusion reaction	Up to Day 180
Secondary	Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units	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).	Prior to Infusion
Secondary	Incidence of Mislabeled UCB Units	Point estimations and 95% confidence intervals of incidences mislabeled UCB units	Up to Day 180
Secondary	Comparison of Specific Cord Blood Banks (CBBs)	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.	Up to Day 180