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Autologous Bone Marrow Stem Cells in Cirrhosis Patients

NCT00713934 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2011-10-04

No results posted yet for this study

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.

Conditions

  • Stem Cell Transplantation
  • Cirrhosis

Interventions

BIOLOGICAL

CD133

portal vein infusion of CD133+ cells

BIOLOGICAL

BM-MNC

portal vein infusion of BM-MNC

Sponsors & Collaborators

  • Small Business Developing Center

    collaborator UNKNOWN

  • Shiraz University of Medical Sciences

    collaborator OTHER

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Hamid Gorabi, PhD · Royan institute, Tehran, Iran

  • Malekhosseini, MD · Liver Transplantation Research Center, Shiraz, Iran

  • Hossein Baharvand, PhD · Royan institute, Tehran, Iran

  • Saman Nikeghbal, MD · Liver Transplantation Research Center, Shiraz, Iran

  • Nasser Aghdami, MD, PhD · Royan institute, Tehran, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

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 NCT00713934 on ClinicalTrials.gov