Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
PhasePhase 1/Phase 2
Lead SponsorAndalusian Initiative for Advanced Therapies
StatusCompleted No Results Posted
Intervention/Treatmentallogeneic adipose derived mesenchymal stem cell ...
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)
Intra-arterial administration through a selective cannulation of target common femoral artery
Group of low dose of Mesenchymal stem cells.
Group of mid dose of mesenchymal stem cells
Controlled group with no intervention
Inclusion Criteria: Diabetes, type 1 or 2 Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb. No options for target limb revascularization. Exclusion Criteria: Cancer antecedent in the last two years Current limb infection or limb gangrene