Autologous Bone Marrow Stem Cells in Cirrhosis Patients

Phase 1

Completed

• Conditions: Stem Cell Transplantation; Cirrhosis
• Interventions: Biological: CD133; Biological: BM-MNC

• Registration Number: NCT00713934
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2010-03
• Last Update Submitted: 2011-10-01
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CD133	-
2	BM-MNC	-

Primary Outcome Measures

Name	Time	Method
Liver function test	6 months
MELD score	6 months

Secondary Outcome Measures

Name	Time	Method
Cirrhosis mortality	6 months

Trial Locations

Locations (2)

Liver Transplant Research Center; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of