Extremitätenerhalt durch autologe Knochenmarksstammzelltransplantation zur Induktion der Arteriogenese bei kritischer, nicht-revaskularisierbarer Extremitätenischämie

BACKGROUND: Bone marrow cell transplantation has been shown to induce angiogenesis and thus improve ischaemic artery disease. This study eval-uates the effects of intramuscular bone marrow cell transplantation in patients with limb-threatening critical limb ischaemia with a very high risk for major amputation. METHODS AND RESULTS: After failed or impossible operative and / or interventional revascularisation and after unsuccessful maximum conservative therapy, 51 patients with impending major amputation due to severe critical limb ischaemia had autologous bone marrow cells (BMC) transplant-ed into the ischaemic leg. Patients 1-12 received Ficoll-isolated bone marrow mononuclear cells (total cell number 1.1 ± 1.1 × 10 9 ), patients 13-51 received point of care isolated bone marrow total nucleated cells (3.0 ± 1.7 × 10 9 ). Limb salvage was 59 % at 6 months and 53 % at last follow-up (mean: 411 ± 261 days, range: 175-1186 days). Per-fusion measured with the ankle-brachial -index (ABI) and transcutaneous oxygen tension (tcpO 2 ) at baseline and after 6 months increased in -patients with consecutive limb salvage (ABI 0.33 ± 0.18 to 0.46 ± 0.15, tcpO 2 12 ± 12 to 25 ± 15 mmHg) and did not change in patients eventually undergoing major amputation. No differences in clinical outcome between the isolation methods were seen. Clinically most important, patients with limb salvage improved from a mean Rutherford category of 4.9 at baseline to 3.3 at 6 months (p = 0.0001). Analgesics consumption was reduced by 62 %. -Total walking distance improved in non-amputees from zero to 40 metres. Three severe peri-procedural adverse events resolved without se-quel-ae, and no unexpected long-term adverse events occurred. CONCLUSIONS: In no-option patients with end-stage critical limb ischaemia due to peripheral -artery disease, bone marrow cell transplantation is a safe procedure which can improve leg perfusion sufficiently to reduce major amputations and permit durable limb salvage.