Lower Extremity Ischemia
Conditions
Keywords
lower extremity ischemia, Bone marrow, Progenitor cells, Neoangiogenesis
Brief 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.
Interventions
PROCEDUREBone 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
PROCEDUREBone marrow aspiration , injection of isolated CD 133+ cells
arm CD133 receives injection of isolated CD 133+ cells
PROCEDUREBone marrow aspiration, injection of saline
arm placebo receives injection of saline
Sponsors
Samara State Medical University
Regional hospital of Samara
Clinical Center of Cellular Technologies, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
39 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increasing of painless walking distance | Within the first 30 days, 6 months and 12 months after injection |
Outcome results
None listed