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Biotech / Medical : Stem Cell Research -- Ignore unavailable to you. Want to Upgrade?

To: SnowShredder who wrote (158)	9/19/2005 1:08:34 PM
From: SnowShredder	Read Replies (1) \| Respond to of 495

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 >>>> 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