Ischemia Clinical Trial
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
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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