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Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

NCT01120925 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-04-28

No results posted yet for this study

Summary

Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.

Conditions

Interventions

BIOLOGICAL

MNC

2-3 X 109 cells in 20ML suspension IPV in 4 min

BIOLOGICAL

CD133

5-15 X 106 cells in 20ML suspension IPV

BIOLOGICAL

Control

Injection of 20 ml Normal saline via IPV

Sponsors & Collaborators

  • University of Tehran

    collaborator OTHER

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Hamid Gourabi, PhD · Royan Institute

  • Reza Malekzadeh, MD · Gastroenterology and hepatic disease research center

  • Hossein Baharvand, PhD · Royan Institute

  • Mohammad Bagheri, MD · Gastroenterology and hepatic disease research center

  • Massoud Vosough, MD · Royan Institute

  • Nasser Aghdami, MD., PhD · Royan Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

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 NCT01120925 on ClinicalTrials.gov