Critical Limb Ischemia (CLI) Clinical Trial
Official title:
Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs: Study of the Needs of Insulin
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency of the intra-arterial infusion of stem cells in diabetic patients type 2 with CLI.
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow,
autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal
stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and
the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency
of the intra-arterial infusion of stem cells in diabetic patients type 2.
Diabetic patients will include with critical ischemia chronicle of at least a low member limb
(CLI) and without possibilities of revascularization. 48 evaluable patients will be included,
of which 36 patients will be included in the experimental group (12 for every cellular group)
and 12 in the group control by conventional treatment. The population to studying will be
constituted by 48 evaluable patients.
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|---|---|---|---|
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