Critical limb ischemia
Somajen C 20 Supraselective
(Intravenous + site of tissue loss) Aimed at wound healing and prevention of further tissue degeneration through revascularization. Prevention of amputation.
Somajen C 20 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)
1Y: 30D, 3M, 6M, 12M Baseline diagnostic tests, DSA & hybrid MRA using a contrast- enhanced 3D gradient- echo volumetric interpolated breath-hold examination with surface coils, followed by three-station bolus chase MR angiography with a dedicated peripheral vascular coil, tests for recognized genetic mutations; G20210A Prothrombin
Anti-inflammation, Endothelial tissue regeneration, revascularization, change in: claudication, ischemic rest pain, visible signs of wound healing; halting of wound enlargement, signs of tissue regeneration. Analysis of maximum- intensity-projection hybrid MR angiograms and DSA images to determine sensitivities and specificities of stenosis & occlusion
Inclusion criteria: Critical Limb Ischemia / diabetic foot disease; peripheral artery disease; M/F (Ag18-70); subjects experiencing ischemic rest pain with visible ulcer(s) / tissue loss and without prohibitive operative risks, recognized genetic mutations may disqualify patients