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Phase I clinical trial demonstrates improved perfusion and functional outcomes in severe limb ischemia, indicating safety and feasibility of combination stem cell therapy.
The infusion of a source of endothelial progenitors (EPCs) to limb ischemia (LB) patients has been used to increase angiogenesis. Because the formation of new blood vessels involves, in addition to EPCs, other cells and angiogenic regulators, we postulate that a combination cell therapy including EPCs and mesenchymal stem cells (a source of pericytes progenitors and angiogenic regulators) may represent a preferential stimuli for the development of blood vessels. In this phase I clinical trial, patients with LI were infused with a cell product consisting of autologous bone marrow-derived mononuclear and mesenchymal stem cells. After 10 2 months of follow-up, efficacy assessment demonstrated improvements in walking time, ankle brachial pressure, and quality of life. Concomitantly, angiographic and 99mTc-TF perfusion scintigraphy scores confirmed increased perfusion in the treated limbs. These results show that the use of a combination cell therapy is safe, feasible, and appears effective in patients with LI.
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Lasala et al. (2010) studied this question.
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