The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil
Wound healing (wound size, wound stage) - monitoring the healing of trophic lesions
Time frame: 3 months
Clinical outcome classification
Improvement of symptoms, functional capacity, exercises tolerance assessed by change in Rutherford scale of CLI
Time frame: 3 months, 6 months
Pain and analgesics use
Time frame: 3 months
Quality of life outcome
Time frame: 3 months, 6 months
Improvement of the coronary and collateral circulation.
Time frame: 3 months
Survival without amputation
Time frame: 6 months
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