Actively Recruiting
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units for Lymphatic Diseases and Hematopoietic Malignancies
Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-05-08
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the use of unlicensed umbilical cord blood (UCB) units as a source of cells for treating lymphatic diseases and hematopoietic malignancies. The study acknowledges that for the next 5 to 10 years or longer, many cord blood units worldwide will remain unlicensed, but some may have attributes making them better suited for certain treatments. Access to unlicensed UCB units is important due to the wide variety of potential applications in cellular therapy and hematopoietic reconstitution. Patients receive pre-infusion treatments including intravenous hydration, acetaminophen, and diphenhydramine or suitable alternatives adjusted by age and weight about 30 minutes before the UCB infusion. The infusion involves minimally manipulated unlicensed UCB units delivered through a central line following institutional guidelines. Vital signs are monitored during and after infusion, and infusion reactions are managed as needed. Post-transplant care and follow-up are conducted according to disease-specific protocols and institutional standards. Participants are registered under this protocol and the specific treatment protocol for their condition. Researchers monitor the incidence of blood-borne pathogen transmission within 24 hours post-infusion, serious infusion reactions up to 180 days, cell counts in the UCB units before infusion, labeling errors, and compare outcomes from different cord blood banks. Follow-up care and evaluations continue according to the disease protocol. The study aims to ensure safety and track the use of unlicensed UCB units over time.
CONDITIONS
Brief Title
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis requiring umbilical cord blood as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution under an IRB-approved treatment protocol
- Written informed consent provided for use of unlicensed UCB units and co-enrollment onto a University of Minnesota IRB-approved clinical trial
- Availability of an unlicensed UCB unit meeting required cell dose and HLA matching criteria, negative for tested blood-borne pathogens, and no equivalent licensed UCB unit available
You will not qualify if you...
- Exclusion criteria are specified in the disease-specific treatment protocol according to indication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single infusion event with immediate monitoring period
Participants receive pre-infusion treatment including intravenous hydration, acetaminophen, and diphenhydramine hydrochloride approximately 30 minutes prior to infusion. The unlicensed umbilical cord blood unit is then infused through a central line according to institutional guidelines with monitoring of vital signs during and after infusion and management of any infusion reactions.
1 infusion visit (in-person) with vital signs monitoring during and after infusion
Duration - Up to 180 days after infusion
Participants receive post-transplant care and follow-up according to disease-specific treatment protocols and institutional guidelines, including monitoring for infusion reactions and other outcomes.
Trial Site Locations
Total: 1 location
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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