Limb salvage using intramuscular injection of unfractionated autologous bone marrow mononuclear cells in critical limb ischemia: a prospective pilot clinical trial

Abstract

Objectives: Despite advances in surgical and radiologic vascular techniques, many patients with critical limb ischemia are not eligible for revascularization procedures. Without pharmacologic therapy, the only option left is amputation. Bone marrow-derived progenitor cells represent a good revascularization option. This study sought to evaluate the therapeutic effectiveness of autologous unfractionated bone marrow mononuclear cell injection in revascularization of critical limb ischemia patients.

Materials and methods: Twenty critical limb ischemia patients were not eligible for open or endo-vascular interventions. Bone marrow mononuclear cells were obtained by aspiration of 300 mL bone marrow, injected intramuscular in affected muscles. Patients were followed-up by walking distance, resting pain, skin condition, and ankle brachial index.

Results: Walking distance improved from a mean of 56 meters to a mean of 132 meters; rest pain improved markedly in 50% of patients, mildly in 5% of patients, and was unaffected in 45% of the patients. Fifty percent of patients showed improved skin condition, while ankle brachial index showed improvement in 40% of patients. No procedure-related complications were encountered.

Conclusions: Autologous bone marrow mononuclear cell injection provides a safe and effective option for critical limb ischemia patients.