Diabetic Foot Clinical Trial
Official title:
Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic
patients with critical limb ischemia due to bellow-the-knee extensive arterial disease.
After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under
sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells)
are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3
minutes.
Clinical and angiographic follow-up will be performed at 3 months after the infusion to
assess the efficacy of autologous mononuclear cells transplantation in terms of:
- Changes in below-the-knee angiography from baseline to 3 months follow-up.
- Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of
main ischemic ulcer will be also assessed at target limb.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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