Diabetes Clinical Trial
Official title:
Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
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)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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