NCT01903044

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pontifícia Universidade Católica do Paraná · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lower Extremity Ischemia
• Leg Ulcer
• Peripheral Vascular Disease
• Diabetic Foot
• Gangrene

Interventions

Type	Name	Description
PROCEDURE	BM-MNC injection	BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-03-01
• Completion: 2018-09-01
• First posted: 2013-07-19
• Last updated: 2017-12-13

Locations

1 site across 1 country: Brazil