Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers

Completed · Phase 1/Phase 2

Conditions studied: Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia

In brief

This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.

Key facts

Study ID

NCT00089596

Run by

ViaCell

People needed

10

Starts

2004-03-01

Expected to finish

2006-10-01

Last updated by the study team

2007-04-12

Who can join

Age: 12 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord
• Stable disease and lack of unrelated donor
• Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features
• ALL in 2nd or subsequent remission or first remission with high risk features
• Myelodysplastic syndrome (MDS)
• Non-Hodgkin Lymphoma (NHL)
• Chronic Myelogenous Leukemia (CML)
• Adequate function of heart, liver, kidneys and lungs

You may not qualify if…

• Females who are pregnant
• Poor ability to perform daily activities
• Weight under 40 kilograms (88 pounds)
• AML caused by chemoradiation
• Prior stem cell transplant
• Uncontrolled infection at time of transplant
• Active fungal infection
• HIV infection
• Primary myelofibrosis
• Receiving other research drugs
• Unable to provide informed consent

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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