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Sponsors and Collaborators: |
Clinical Center of Cellular Technologies, Russia State medical University of Samara Regional hospital of Samara |
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Information provided by: | Clinical Center of Cellular Technologies, Russia |
ClinicalTrials.gov Identifier: | NCT00753025 |
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
Condition | Intervention | Phase |
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Lower Extremity Ischemia |
Procedure: Bone marrow aspiration, injection of cells Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells Procedure: Bone marrow aspiration, injection of saline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells |
Enrollment: | 42 |
Study Start Date: | October 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CD133: Experimental |
Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells
arm "CD133" receives injection of isolated CD 133+ cells
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TNC: Experimental |
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 |
Placebo: Placebo Comparator |
Procedure: Bone marrow aspiration, injection of saline
arm "placebo" receives injection of saline
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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.
Ages Eligible for Study: | 39 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Clinical Center of Cellular Technologies, Russia ( Andrey Toropovskiy ) |
Study ID Numbers: | CCCT001 |
Study First Received: | September 9, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00753025 History of Changes |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
lower extremity ischemia Bone marrow Progenitor cells Neoangiogenesis |
Arterial Occlusive Diseases Arteriosclerosis Obliterans Vascular Diseases |
Neovascularization, Pathologic Ischemia Arteriosclerosis |
Arterial Occlusive Diseases Pathologic Processes Arteriosclerosis Obliterans Vascular Diseases |
Cardiovascular Diseases Arteriosclerosis Ischemia |