Stem Cell Transplantation, Cirrhosis
Conditions
Keywords
Autologous Bone marrow stem cells, Cirrhosis
Brief 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.
Detailed 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.
Interventions
Sponsors
Small Business Developing Center
Shiraz University of Medical Sciences
Royan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function test | 6 months |
| MELD score | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Cirrhosis mortality | 6 months |
Countries
Iran
Outcome results
None listed