NCT00476060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

4.6 years

First QC Date

May 16, 2007

Last Update Submit

May 13, 2023

Conditions

Cirrhosis

Keywords

CirrhosisBone marrowMesenchymal stem cellMELD scoreQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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).

    One year

Secondary Outcomes (1)

  • All cause mortality, tracking the infused cells in the patients' bodies.

    One year

Study Arms (2)

A

EXPERIMENTAL
Procedure: Autologous mesenchymal stem cell transplantation

B

PLACEBO COMPARATOR
Procedure: Autologous mesenchymal stem cell transplantation

Interventions

Autologous mesenchymal stem cell transplantationPROCEDURE

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

AB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Research Center, Shariati Hospital

Tehran, 14117-13135, Iran

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 21, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

IR(1)