Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis

May 13, 2023 updated by: Mehdi Mohamadnejad, University of Tehran

Autologous Mesenchymal Stem Cell Transplantation in Patients With Decompensated Cirrhosis: A Randomized Placebo-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality, tracking the infused cells in the patients' bodies.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDRC85-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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