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Trial NCT00713934

Resource URI: http://static.linkedct.org/resource/trials/NCT00713934
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13829>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/188>
linkedct:brief_title Autologous Bone Marrow Stem Cells in Cirrhosis Patients
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/4678>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/7273>
linkedct:condition <http://static.linkedct.org/resource/condition/12524>
linkedct:condition <http://static.linkedct.org/resource/condition/2908>
linkedct:criteria Inclusion Criteria: - Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score) - Alkaline phosphatase between 2 X to 3X normal value - liver Cirrhosis in Sonography study - Incomplete response to UDCA after 6 months of treatment. - Negative pregnancy test (female patients in fertile age) - written consent Exclusion Criteria: - Presence of active hepatic encephalopathy - Refractory ascites - Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT > 3 times normal in patients with autoimmune hepatitis) - Hepatocellular carcinoma or other malignancies - sepsis - Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.) - HIV, HBV or HCV infection - Cardiac, renal or respiratory failure - Active thrombosis of the portal or hepatic veins - INR>2
linkedct:description BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date February 2009
linkedct:enrollment 7 (xsd:int)
linkedct:firstreceived_date July 9, 2008
linkedct:has_dmc Yes
linkedct:id NCT00713934
linkedct:intervention <http://static.linkedct.org/resource/intervention/61183>
linkedct:intervention <http://static.linkedct.org/resource/intervention/61184>
rdfs:label Trial NCT00713934
linkedct:lastchanged_date February 21, 2009
linkedct:lead_sponsor_agency Royan Institute
linkedct:location <http://static.linkedct.org/resource/location/73021>
linkedct:location <http://static.linkedct.org/resource/location/73053>
linkedct:nct_id NCT00713934
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Autologous Transplantation of Bone Marrow Derived CD 133 Positive Stem Cell and Mono Nuclear Cell (MNC) Transplantation in Patients With Decompensate Cirrhosis: Randomized Clinical Trial
linkedct:org_study_id Liver-001
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/21478>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/23026>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/36750>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/43151>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/52680>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00713934>
linkedct:phase Phase 1/Phase 2
linkedct:primary_completion_date January 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/47198>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/47254>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/26751>
linkedct:source Royan Institute
linkedct:start_date January 2008
linkedct:study_design Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it`s serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.
rdf:type linkedct:trials
linkedct:verification_date February 2009