THE CELLULAR THERAPY FOR THE CRITICAL LIMB ISCHEMIA
Peter Kubisz, Peter Chudý, Ján Hudeček, Igor Šinák, Renáta Talapková, Ľuboš Hlinka, Lenka Patkaňová, Daniela Chudá, Ján Staško and Ľudovít Laca
National Center of Hemostasis and Thrombosis, Clinic of Hematology and Transfusiology JFM CU, Kollárova 2, 036 59 Martin, Slovakia
Abstract:
Introduction: Therapeutic angiogenesis (TA) using bone-marrow-derived mononuclear cells (BMMNC) is a promising option for the salvage of ischemic limb in patients with nonreconstructable critical limb ischemia (CLI). A prospective clinical study to assess efficacy and safety of the TA was conduced.
Methods: CLI patients (n=38) were enrolled. Bone marrow (600±50 ml) was collected from the iliac spine. Heparin solution in saline (80 IU/ml) was used as anticoagulant. Centrifugation (2min, 3100rpm, 22°C) was employed. BMMNC were separated by Optipress and implanted to the ischemic limb using deep intramuscular injections. Patients were followed up for 6 months - 4 years. The local finding, pain intensity, ankle-brachial index (ABI) and claudication interval were assessed.
Results: Total number of procedures was n=41 (3 patients were re-transplant after>6 months). Major amputations n=10 (26%); mortality n=2 (5%); limb salvage n=26 (68%).ABI improved, pain index decreased and claudication interval prolonged.
Conclusions: TA appears to be efficacious and safe therapeutic option for the CLI patients with no possibility of revascularization.
Acknowledgement: This study was supported by ESF (ITMS 26110230031) and CEVYPET (ITMS 26220120053) which are co-financed from EC sources. By Grant of the Ministry of Health of the Slovak Republic 2006/36-MFN-03 and by Grant VEGA 1/0016/12.
