Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis

NCT ID: NCT00476060

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-08-31

Brief Summary

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.

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: EXPERIMENTAL

Autologous mesenchymal stem cell transplantation

Intervention Type: PROCEDURE

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

B

Group Type: PLACEBO_COMPARATOR

Autologous mesenchymal stem cell transplantation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tehran

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Mohamadnejad

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Malekzadeh, M.D

Role: STUDY_CHAIR

Digestive Disease Research Center, Medical Sciences/ University of Tehran

Ardeshir Ghavamzadeh, M.D.

Role: STUDY_CHAIR

Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran

Mehdi Mohamadnejad, M.D.

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Center, Medical Scineces/ University of Tehran

Kamran Alimoghaddam, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran

Locations

Digestive Disease Research Center, Shariati Hospital

Tehran, , Iran

Countries

Iran

Other Identifiers

DDRC85-13

Identifier Type: -

Identifier Source: org_study_id