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Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

Diabetic Foot Clinical Trial

Official title:
Multicentric Study of the Autologous Bone Marrow-derived Mononuclear Cells Injection for Treatment of the Patients With Critical Lower Extremity Ischemia

Clinical Trial Summary

The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

Clinical Trial Description

Critical limb ischemia (CLI) is a debilitating and disabling disease. Symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. Despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. Recent evidence indicates that bone marrow-derived mononuclear cells (BM-MNC) are a potential new therapeutic target. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01903044
Study type Interventional
Source Pontifícia Universidade Católica do Paraná
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 2014
Completion date September 2018
View Details
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