Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis - Full Text View

Sponsor:	University of Tehran
Information provided by:	University of Tehran
ClinicalTrials.gov Identifier:	NCT00476060

Purpose

The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo-controlled trial in 50 patients with decompensated cirrhosis.

Condition	Intervention	Phase
Cirrhosis	Procedure: Autologous mesenchymal stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Autologous Mesenchymal Stem Cell Transplantation in Patients With Decompensated Cirrhosis: A Randomized Placebo-controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by University of Tehran:

Primary Outcome Measures:

MELD score, quality of life, liver volume, histological improvement (In a subset of patients with evidences of clinical and biochemical improvement, follow up liver biopsy will be performed at the end of follow up). [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All cause mortality, tracking the infused cells in the patients' bodies. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	January 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Procedure: Autologous mesenchymal stem cell transplantation Arm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein
Placebo Comparator: B	Procedure: Autologous mesenchymal stem cell transplantation Arm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein

Detailed Description:

The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations, including small donor pool, long waiting list, and several complications. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial. After assignment of the written informed consent, thirty six patients with decompensated cirrhosis will be enrolled, and will be randomized by block randomization into treatment or placebo arm. All the enrolled patients will be in the waiting list of liver transplantation. In the treatment arm bone marrow of the patients will be aspirated, and autologous bone marrow mesenchymal stem cells will be cultured, and then will be infused through a peripheral vein. Also, the corresponding placebo will be infused for the placebo group. The patients will be followed up for 1 year after performing the procedure.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cirrhosis (diagnosed by clinical, biochemical, sonographic, and histologic evidences of cirrhosis) (Patients will have histological documentation of cirrhosis before enrollment. However, for those with evidences of severe coagulopathy liver biopsy may not be performed)
Evidences of decompensated liver disease at screening (e.g. child class B, or C)

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
Active infectious disease
Presences of severe underlying cardiac, pulmonary, or renal disease
Alcohol use in the last 3 months before screening
Use of hepatotoxic drugs in the last 3 months before screening
Unwilling to assign the informed consent
Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
Positive HIV ab
Positive HBsAg with detectable HBV DNA PCR
Positive HCV Ab with detectable HCV RNA PCR
Active thrombosis of the portal or hepatic veins
Serum Cr > 1.8 mg/dL at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476060

Locations

Iran, Islamic Republic of
Digestive Disease Research Center, Shariati Hospital
Tehran, Iran, Islamic Republic of, 14117-13135

Sponsors and Collaborators

University of Tehran

Investigators

Study Chair:	Reza Malekzadeh, M.D	Digestive Disease Research Center, Medical Sciences/ University of Tehran
Study Chair:	Ardeshir Ghavamzadeh, M.D.	Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran
Principal Investigator:	Mehdi Mohamadnejad, M.D.	Digestive Disease Research Center, Medical Scineces/ University of Tehran
Principal Investigator:	Kamran Alimoghaddam, M.D.	Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran

More Information

No publications provided

Responsible Party:	Reza Malekzadeh, Digestive Disease Research Center, Medical Sciences/ University of Tehran
ClinicalTrials.gov Identifier:	NCT00476060 History of Changes
Other Study ID Numbers:	DDRC85-13
Study First Received:	May 16, 2007
Last Updated:	January 10, 2011
Health Authority:	Iran: Ministry of Health

Keywords provided by University of Tehran:

Cirrhosis
Bone marrow
Mesenchymal stem cell
MELD score
Quality of life

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012