NCT00713934

Brief Summary

Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

2 active sites

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, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

October 4, 2011

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

July 9, 2008

Last Update Submit

October 1, 2011

Conditions

Stem Cell TransplantationCirrhosis

Keywords

Autologous Bone marrow stem cellsCirrhosis

Outcome Measures

Primary Outcomes (2)

  • Liver function test

    6 months

  • MELD score

    6 months

Secondary Outcomes (1)

  • Cirrhosis mortality

    6 months

Study Arms (2)

1

EXPERIMENTAL
Biological: CD133

2

EXPERIMENTAL
Biological: BM-MNC

Interventions

CD133BIOLOGICAL

portal vein infusion of CD133+ cells

1
BM-MNCBIOLOGICAL

portal vein infusion of BM-MNC

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
  • Alkaline phosphatase between 2 X to 3X normal value
  • liver Cirrhosis in Sonography study
  • Incomplete response to UDCA after 6 months of treatment.
  • Negative pregnancy test (female patients in fertile age)
  • written consent

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
  • sepsis
  • Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
  • HIV, HBV or HCV infection
  • Cardiac, renal or respiratory failure
  • Active thrombosis of the portal or hepatic veins
  • INR\>2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liver Transplant Research Center

Shiraz, Fars, Iran

Location

Royan Institute

Tehran, Tehran Province, 1665659911, Iran

Location

Related Publications (1)

  • Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.

    PMID: 21194255DERIVED

Related Links

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hamid Gorabi, PhD

    Royan institute, Tehran, Iran

    STUDY CHAIR

  • Malekhosseini, MD

    Liver Transplantation Research Center, Shiraz, Iran

    STUDY CHAIR

  • Hossein Baharvand, PhD

    Royan institute, Tehran, Iran

    PRINCIPAL INVESTIGATOR

  • Saman Nikeghbal, MD

    Liver Transplantation Research Center, Shiraz, Iran

    PRINCIPAL INVESTIGATOR

  • Nasser Aghdami, MD, PhD

    Royan institute, Tehran, Iran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 14, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

October 4, 2011

Record last verified: 2010-03

Locations

IR(2)