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The first U.S. Food and Drug Administration (FDA)–approved randomized clinical trials for saving lower limbs by the patient’s own bone marrow stem cell transplants have been under way since 2007. The initial results are encouraging and provide promise that this form of cell therapy could play a future role in managing advanced peripheral arterial occlusive disease.
Aggressive endovascular therapy with angioplasty and stenting and open surgical approaches with distal vein grafting have reduced the amputation rates in many communities. However, approximately 30% of patients with peripheral artery disease exhaust these options and face amputation if nothing more can be done to improve peripheral perfusion.
The transplantation of the patient’s own mononuclear stem cells (e.g., CD34 cells) from iliac crest bone marrow appears to be another important new option for limb salvage. In fact, bone marrow transplants, a relatively easy technical procedure, may become the first option in treating patients with early critical limb ischemia (CLI).
Bone marrow contains progenitor CD34 cells that can migrate to ischemic tissue to form new blood vessels. These progenitor cells adhere to ischemic endothelium and then migrate into the local environ to cause vasculogenesis. The biology of this complicated process has been studied extensively in the laboratory and is now the basis for human clinical trials.
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