Autologous Bone Marrow Stem Cells in Cirrhosis Patients

Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713934
• Other study ID #: Liver-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 9, 2008
• Last updated: October 1, 2011
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis
• Stem Cell Transplantation

Intervention

Biological:
• CD133
portal vein infusion of CD133+ cells
• BM-MNC
portal vein infusion of BM-MNC

Locations

Country	Name	City	State
Iran, Islamic Republic of	Liver Transplant Research Center	Shiraz	Fars
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Royan Institute	Shiraz University of Medical Sciences, Small Business Developing Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function test		6 months	Yes
Primary	MELD score		6 months	Yes
Secondary	Cirrhosis mortality		6 months	No

External Links

•   Royan Institute
•   Shiraz University Of Medical Sciences, Transplantation Research center