NCT00753025

Autologous Bone Marrow For Lower Extremity Ischemia Treating

Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Clinical Center of Cellular Technologies, Russia · Other Government
• Sex: Male
• Age: 39 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether autologous bone marrow derived cells and isolated CD133+ fraction are effective in the treatment limb ischemia

Detailed description

The number of patients with low limb obliterating atherosclerosis steadily grows and compounds more than 20-25 % from all kinds of a cardiovascular pathology. At conservation of this tendency to 2020 the amputation percentage executed due to vessel diseases, can reach 45 %. Hemodynamics improvement in an extremity by surgery is possible at 40 - 70 % of patients even with the widespread and plural lesion of arteries, but results are not always satisfactory. The most actual is the problem of angiosurgical help to patients with distal forms of arterial occlusions, due to the difficulty or impossibility performing reconstructive interventions. In these cases the operations of an indirect revascularization referred on stimulation of a collateral blood flow are carried out. However, despite the reached successes, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. To date the most perspective methods of neoangiogenesis stimulation are a cellular therapy and gene-engineering technologies. Experimental researches on a model of local limb ischemia showed possibility of use of various cells for neoangiogenesis stimulation. A number of clinical researches at patients with obliterating limb diseases has shown efficacy of cellular therapy even at a critical ischemia. However randomized, the placebo-controlled researches based on principles of evidence based medicine while it is not enough for the convincing conclusions.

Conditions

• Lower Extremity Ischemia

Interventions

Type	Name	Description
PROCEDURE	Bone marrow aspiration, injection of cells	Bone marrow is aspirated at patients in all arms. Arm "TNC" receives injection of total nucleated cells into ischemic muscle
PROCEDURE	Bone marrow aspiration , injection of isolated CD 133+ cells	arm "CD133" receives injection of isolated CD 133+ cells
PROCEDURE	Bone marrow aspiration, injection of saline	arm "placebo" receives injection of saline

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-06-01
• Completion: 2008-02-01
• First posted: 2008-09-16
• Last updated: 2008-09-16