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Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis

NCT00476060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

  • Cirrhosis

Interventions

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

Sponsors & Collaborators

  • University of Tehran

    lead OTHER

Principal Investigators

  • Reza Malekzadeh, M.D · Digestive Disease Research Center, Medical Sciences/ University of Tehran

  • Ardeshir Ghavamzadeh, M.D. · Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran

  • Mehdi Mohamadnejad, M.D. · Digestive Disease Research Center, Medical Scineces/ University of Tehran

  • Kamran Alimoghaddam, M.D. · Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476060 on ClinicalTrials.gov