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Study 1 of 155 for search of: | Iran, Islamic Republic of |
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Sponsors and Collaborators: |
Royan Institute Tehran University of Medical Sciences |
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Information provided by: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT00677404 |
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.
Condition | Intervention | Phase |
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Peripheral Vascular Diseases Ischemia |
Biological: BM-MNC Biological: BM-MNC and G-CSF |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Clinical Outcome in Advanced Chronic Lower Limb Ischemia by Stem Cell Transplantation With or Without (Granulocyte-Colony Stimulation Factor) G-CSF Injection |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
BM-MNC
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Biological: BM-MNC
Bone marrow aspiration A total volume of 400 ml bone marrow will be aspirated from the iliac crest under epidural anaesthesia
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2: Experimental
BM-MNC and G-CSF
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Biological: BM-MNC and G-CSF
Bone marrow aspiration A total volume of 400 ml bone marrow will be aspirated from the iliac crest under epidural anaesthesia and Subcutaneous injection of G-CSF (10 microgr/day) from day of cell injection for 5 days
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Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes we might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. The EPCs resident within bone marrow and peripheral blood, so it seems implantation of BM cells can contribute to injury-induced and pathology induced neovascularization. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in both ischemic limb models and patients with limb ischemia. In addition, granulocyte-colony stimulation factor could mobilize the EPCs to peripheral blood. After BM-MNC implantation, G-CSF can contribute more EPC in PB for effective angiogenesis in PAD patients.
In this study, Bone marrow puncture will be performed in a common manner. The iliac crest is punctured under epidural anesthesia and 400 mL of bone marrow will be aspirated. The MNCs are isolated under good manufacturing practice conditions by Ficoll density separation and is intramuscularly injected (40 sites, in 3 × 3 cm distance, 1-1.5 cm deep, into ischemic leg. In some patients G-CSF (10 microgr/day) is administration by subcutaneous injection from day of cell injection for 5 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nasser Aghdami, MD., PhD | 98-21-2630-0017 | Nasser.aghdami@royaninstitute.org |
Contact: Hassan Ravari, MD | 98-21-6673-5018 | hassanravari@yahoo.com |
Iran, Islamic Republic of | |
Royan Institute | Recruiting |
Tehran, Iran, Islamic Republic of, 1665659911 | |
Contact: Nasser Aghdami, MD., PhD 98-21-2630-0017 Nasser.aghdami@ki.se | |
Sub-Investigator: Mehrnaz Namiri, Ms | |
Tehran University of medical sciences, Vascular Surgery department, Sina Hospital | Recruiting |
Tehran, Iran, Islamic Republic of | |
Contact: Hassan Ravari, MD 98-21-6673-5018 hassanravari@yahoo.com |
Study Chair: | Hamid Gorabi, PhD | Royan institute, Tehran, Iran |
Study Chair: | Mohammad reza Zafarghandi, MD | Sina Hospital, Tehran, Iran |
Study Director: | Nasser Aghdami, MD., PhD | Royan institute, Tehran, Iran |
Principal Investigator: | Hossein Baharvand, PhD | Royan institute, Tehran, Iran |
Principal Investigator: | Hassan Ravari, MD | Sina Hospital, Tehran, Iran |
Responsible Party: | Royan Institute ( Hamid Gourabi, Chief ) |
Study ID Numbers: | Royan-PVD-001 |
Study First Received: | May 12, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00677404 |
Health Authority: | Iran: Ministry of Health |
Peripheral vascular diseases chronic lower limb ischemia |
Peripheral Vascular Diseases Vascular Diseases Ischemia |
Pathologic Processes Cardiovascular Diseases |