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	Treatment or Intervention	Phase
Acute Lymphocytic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndrome	Procedure: Expansion of umbilical cord stem cells	Phase I Phase II

Ages Eligible for Study:  16 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

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)
• Adequate function of heart, liver, kidneys and lungs

Exclusion Criteria:

• Females who are pregnant
• Poor ability to perform daily activities
• AML caused by chemoradiation
• Prior stem cell transplant
• Uncontrolled infection at time of transplant
• Active fungal infection
• HIV infection
• Certain types of myelofibrosis
• Receiving other research drugs
• Unable to provide informed consent

Jo Fladger      617-914-3501    jfladger@viacellinc.com

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting
New Jersey
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting

Study chairs or principal investigators

Kurt Gunter, MD,  ViaCell   

Study ID Numbers:  CB001
Record last reviewed:  October 2004
Record first received:  August 6, 2004
ClinicalTrials.gov Identifier:  NCT00089596
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10