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Autologous Transplantation of Bone Marrow Mononuclear Cell (BM-MNC) With and Without Granulocyte-Colony Stimulation Factor (G-CSF) for Treatment of Chronic Lower Limb Ischemic Patients

NCT00677404 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-07-29

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of mononuclear cells with and without G-CSF in patients with chronic lower limb ischemia.

Conditions

  • Peripheral Vascular Diseases
  • Ischemia

Interventions

BIOLOGICAL

BM-MNC injection

Bone marrow aspiration A total volume of 400 ml bone marrow will be aspirated from the iliac crest under epidural anaesthesia

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    collaborator OTHER

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

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

  • Mohammad reza Zafarghandi, MD · Sina Hospital, Tehran, Iran

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

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

  • Hassan Ravari, MD · Sina Hospital, Tehran, Iran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-10-31
Completion
2010-01-31

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 NCT00677404 on ClinicalTrials.gov