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Autologous Bone Marrow Stem Cells in Cirrhosis Patients

Primary Purpose

Stem Cell Transplantation, Cirrhosis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

CD133

BM-MNC

About this trial

This is an interventional treatment trial for Stem Cell Transplantation focused on measuring Autologous Bone marrow stem cells, Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Liver Transplant Research Center
Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Liver function test

MELD score

Secondary Outcome Measures

Cirrhosis mortality

Full Information

NCT ID

NCT00713934

First Posted

July 9, 2008

Last Updated

October 1, 2011

Sponsor

Royan Institute

Collaborators

Small Business Developing Center, Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00713934

Brief Title

Autologous Bone Marrow Stem Cells in Cirrhosis Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

Collaborators

Small Business Developing Center, Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stem Cell Transplantation, Cirrhosis

Keywords

Autologous Bone marrow stem cells, Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

CD133

Intervention Description

portal vein infusion of CD133+ cells

Intervention Type

Biological

Intervention Name(s)

BM-MNC

Intervention Description

portal vein infusion of BM-MNC

Primary Outcome Measure Information:

Title

Liver function test

Time Frame

6 months

Title

MELD score

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Cirrhosis mortality

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: