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

This study has been completed.
Information provided by:
ViaCell Identifier:
First received: August 6, 2004
Last updated: April 11, 2007
Last verified: April 2007
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.

Condition Intervention Phase
Acute Lymphocytic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndrome Non-Hodgkin Lymphoma Chronic Myelogenous Leukemia Procedure: Expansion of umbilical cord stem cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation

Resource links provided by NLM:

Further study details as provided by ViaCell:

Estimated Enrollment: 10
Study Start Date: March 2004
Estimated Study Completion Date: October 2006

Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00089596

United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Study Director: Kurt Gunter, MD ViaCell
  More Information Identifier: NCT00089596     History of Changes
Obsolete Identifiers: NCT00301704
Other Study ID Numbers: CB001
Study First Received: August 6, 2004
Last Updated: April 11, 2007

Keywords provided by ViaCell:
umbilical cord blood

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders processed this record on September 21, 2017