Trial | NCT00713934  Report issue

Title

Autologous Bone Marrow Stem Cells in Cirrhosis Patients
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    7
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.
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.
Study Started
Jan 31
2008
Primary Completion
Jan 31
2009
Study Completion
Feb 28
2009
Last Update
Oct 04
2011
Estimate

Biological CD133

portal vein infusion of CD133+ cells

Biological BM-MNC

portal vein infusion of BM-MNC

1 Experimental

2 Experimental

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
No Results Posted