Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
Here is the protocol for the halted cord blood trial.
clinicaltrials.gov
Best of Luck,
SS
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Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
This study is currently recruiting patients.
Verified by ViaCell December 2004
Sponsored by: ViaCell
Information provided by: ViaCell
ClinicalTrials.gov Identifier: NCT00089596
Purpose
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
Procedure: Expansion of umbilical cord stem cells
Phase I
Phase II
MedlinePlus related topics: Blood and Blood Disorders; Bone Marrow Diseases; Cancer; Cancer Alternative Therapies; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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
Further Study Details:
Expected Total Enrollment: 16
Study start: March 2004
Eligibility
Ages Eligible for Study: 12 Years - 60 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
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00089596
Jo Fladger 617-914-3501 jfladger@viacellinc.com
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting
John Wagner, MD, Principal Investigator
New Jersey
Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States; Recruiting
Scott Rowley, MD, Principal Investigator
Ohio
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States; Recruiting
Mary Laughlin, MD, Principal Investigator
Study chairs or principal investigators
Kurt Gunter, MD, ViaCell
More Information
Study ID Numbers: CB001
Last Updated: July 25, 2005
Record first received: August 6, 2004
ClinicalTrials.gov Identifier: NCT00089596
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-16 |
