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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.

Secondary study objectives

Comparison of Specific Cord Blood Banks (CBBs)

Incidence of Mislabeled UCB Units

Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 1Eligibility criteria met