Early results and lessons learned from a multicenter, randomized, double-blind trial of bone marrow aspirate concentrate in critical limb ischemia Academic Article uri icon


MeSH Major

  • Bone Marrow Transplantation
  • Ischemia
  • Lower Extremity


  • In this multicenter, randomized, double-blind, placebo-controlled trial of autologous bone marrow cell therapy for CLI, the therapy was well tolerated without significant adverse events. The BMAC group demonstrated trends toward improvement in amputation, pain, quality of life, Rutherford classification, and ABI when compared with controls. This pilot allowed us to identify several areas for improvement for future trials and CLI studies. These recommendations include elimination of treadmill testing, stratification by Rutherford class, and more liberal inclusion of patients with renal insufficiency. Our strongest recommendation is that CLI studies that include Rutherford 4 patients should incorporate a composite endpoint reflecting pain and quality of life.

publication date

  • December 2011



  • Academic Article



  • eng

Digital Object Identifier (DOI)

  • 10.1016/j.jvs.2011.06.118

PubMed ID

  • 22019148

Additional Document Info

start page

  • 1650

end page

  • 8


  • 54


  • 6