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Stem Cell Transplantation
Umbilical Cord Blood Transplant for Blood Cancers
N/A
Recruiting
Led By John Wagner, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 180
Awards & highlights
Summary
This trial will allow access to unlicensed UCB units for the next 5-10 years.
Who is the study for?
This trial is for patients needing a stem cell transplant to treat blood or lymphatic diseases and who have an unlicensed umbilical cord blood (UCB) unit that matches their needs. The UCB must be free of pathogens, with no equivalent licensed option available. Participants must consent to use the UCB as part of another approved treatment plan.
What is being tested?
The study tests the infusion of unlicensed UCB units in treating various conditions requiring hematopoietic stem cells from cord blood after intensive chemotherapy or radiation therapy, known as myeloablative or non-myeloablative conditioning.
What are the potential side effects?
Potential side effects may include reactions similar to blood transfusions, such as fever and chills, allergic reactions, increased risk of infection due to immune suppression from conditioning treatments prior to infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a treatment that requires stem cells from umbilical cord blood after a bone marrow preparation procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
Secondary outcome measures
Comparison of Specific Cord Blood Banks (CBBs)
Incidence of Mislabeled UCB Units
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Unlicensed Umbilical Cord Blood InfusionExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
278 Previous Clinical Trials
15,341 Total Patients Enrolled
John Wagner, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
4 Previous Clinical Trials
37 Total Patients Enrolled
Claudio Brunstein, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
2 Previous Clinical Trials
202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I (or my guardian) have agreed to use an experimental treatment as part of a clinical trial.I am eligible for a treatment that requires stem cells from umbilical cord blood after a bone marrow preparation procedure.I have a cord blood unit that matches and is free of blood-borne diseases, not from a licensed bank.
Research Study Groups:
This trial has the following groups:- Group 1: Unlicensed Umbilical Cord Blood Infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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