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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
A Journal on Vascular and Endovascular Surgery
PERIPHERAL ARTERIAL DISEASES
Italian Journal of Vascular and Endovascular Surgery 2014 December;21(4):191-200
No-option critical limb ischemia revascularization with stem cell therapy
Prochazka V. 1, Gumulec J. 2, Jalůvka F. 3, Kusinova P. 1, Jonszta T. 1, Czerny D. 1, Krajca J. 1, Urbanec R. 4, Pavliska L. 5, Vitkova K. 5, Spackova I. 1, Jurcikova J. 5
1 Department of Radiology, University Hospital Ostrava, Ostrava, Czech Republic;
2 Department of Hemato‑Oncology, University Hospital Ostrava, Ostrava, Czech Republic;
3 Department of Surgery, University Hospital Ostrava, Ostrava, Czech Republic;
4 Department of Anesthesiology and resuscitation, University Hospital Ostrava, Czech Republic;
5 Department of Vice‑President for Science and Research, University Hospital Ostrava, Ostrava, Czech Republic;
6 Laboratore AGEL, a.s., Novy Jicin, Czech Republic
AIM AND METHODS: Peripheral arterial occlusive disease (PAOD) has been recognized as a significant factor in the population of patients with critical limb ischemia. In total 49% of patients presenting with a new diabetic foot ulcer had PAOD. Critical limb ischemia (CLI) develops suddenly, and is responsible for 50-67% of all nontraumatic lower extremity amputations. Fifty two per cent of diabetics with CLI die during the 4.5-year follow-up. The SmartPreP2 centrifuge gradient density centrifugation resulted in at least a 7.16 fold concentration of CD34+ cells in the bone marrow concentrate and more than 6.2 fold concentration of mononuclear cells (compared to a sample of BMA aspirate before centrifugation). The gradient density centrifugation increased the concentration of platelets about 3.9 fold while preserving the relative concentrations of other cells in the host BMAC. The procedure of stem cells transplantation is performed under intravenous single-shot antibiotics, in order to avoid infection with skin bacteria during the multiple intramuscular injections. The quality of tissue perfusion can be measured before and after BMAC transplantation with Laser Doppler flowmetry with PeriFlux System 5000.
RESULTS: The clinical results of cell therapy were analysed in a systematic search of randomized control trials (RCTs) of BM-derived cell therapy in NO-CLI patients. In the placebo-controlled RCTs, including a separate control group, the observed beneficial effect on amputation rates in the cell therapy group compared with the group treated with placebo was considerably reduced, when compared to the meta-analyses including all RTCs with RR 0.92 (95%CI, 0.51-1.67; P=0.78). In BMMNC trials, the amputation rate in the Tx group was 14.8% against 25.4% in the control study group (P=0.0278).
CONCLUSION: Multicellular therapy using BMAC from bone marrow aspirate maximizes the reciprocal interactions between the various transplanted cells of the bone marrow, as well as the interaction of these cells with the extracellular matrix.