A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group. In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Intra-arterial administration through a selective cannulation of target common femoral artery
University Hospital Virgen Macarena
Seville, Seville, Spain
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, Seville, Spain
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
Time frame: 6 months
Major adverse event (death, target limb amputation)
Time frame: 1 month, 6 months, 12 months
Ankle Brachial Index
Time frame: 1 month, 6 months, 12 months
University of Texas Classification at target limb
Time frame: 1 month, 6 months, 12 months
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