title: [Autologous bone-marrow stem-cell transplantation for induction of arteriogenesis for limb salvage in critical limb ischaemia].
abstract: BACKGROUND
  Bone marrow cell transplantation has been shown to induce angiogenesis and thus improve ischaemic artery disease. This study evaluates the effects of intramuscular bone marrow cell transplantation in patients with limb-threatening critical limb ischaemia with a very high risk for major amputation.
  
  
  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 x 10(9)), patients 13-51 received point of care isolated bone marrow total nucleated cells (3.0 +/- 1.7 x 10(9)). Limb salvage was 59 % at 6 months and 53 % at last follow-up (mean: 411 +/- 261 days, range: 175-1186 days). Perfusion measured with the ankle-brachial-index (ABI) and transcutaneous oxygen tension (tcpO2) at baseline and after 6 months increased in -patients with consecutive limb salvage (ABI 0.33 +/- 0.18 to 0.46 +/- 0.15, tcpO2 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 sequelae, 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.
authors.affiliation: Franziskuskrankenhaus, Innere Abteilung, Berlin, Deutschland. amann@franziskus-berlin.de
authors.forename: B
authors.initials: B
authors.lastname: Amann
authors.forename: C
authors.initials: C
authors.lastname: Lüdemann
authors.forename: R
authors.initials: R
authors.lastname: Ratei
authors.forename: J A
authors.initials: JA
authors.lastname: Schmidt-Lucke
mesh_terms: D000368:Aged; D000792:Angiography; D016026:Bone Marrow Transplantation / Q000379:methods*; D002452:Cell Count; D003097:Collateral Circulation / Q000502:physiology; D003925:Diabetic Angiopathies / Q000601:surgery; D017719:Diabetic Foot / Q000601:surgery; D018572:Disease-Free Survival; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D007511:Ischemia / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000209:etiology; D020858:Tissue and Organ Harvesting; D014945:Wound Healing / Q000502:physiology