Autologous Bone Marrow For Lower Extremity Ischemia Treating

Clinical Center of Cellular Technologies, Russia

Status and phase: Completed; Phase 2

Conditions: Lower Extremity Ischemia

Treatments: Procedure: Bone marrow aspiration, injection of saline; Procedure: Bone marrow aspiration, injection of cells; Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00753025

CCCT001

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: Male

Ages: 39 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)
• a painless walking distance of 10-50 m
• pulse absence on аа. dorsalis pedis, tibialis posterior, poplitea
• absence of a ischemia in a rest and necrotic changes
• mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance
• patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously
• heavy smokers

Exclusion criteria

• insulin depended diabetes
• myocardial infarction or a stroke within last year
• an idiopathic hypertensia III stage
• anaemia and other diseases of blood
• decompensation of the chronic diseases which are contraindications to any surgical operation
• HIV infection
• a virus hepatitis
• oncologic diseases
• chemotherapy in the anamnesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

CD133

Experimental group

Treatment:

Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells

TNC

Experimental group

Treatment:

Procedure: Bone marrow aspiration, injection of cells

Placebo

Placebo Comparator group

Treatment:

Procedure: Bone marrow aspiration, injection of saline