Autologous Bone Marrow Stem Cells in Cirrhosis Patients

Royan Institute

Status and phase

Completed

Phase 2

Phase 1

Conditions

Stem Cell Transplantation

Cirrhosis

Treatments

Biological: BM-MNC

Biological: CD133

Study type

Interventional

Funder types

Other

Identifiers

NCT00713934

Liver-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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