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A Randomized, Controlled Pilot Study of Autologous CD34+ Cell Therapy for Critical Limb Ischemia

2012; Lippincott Williams & Wilkins; Volume: 5; Issue: 6 Linguagem: Inglês

10.1161/circinterventions.112.968321

1941-7632

Douglas W. Losordo, Melina R. Kibbe, Farrell O. Mendelsohn, William A. Marston, Vickie R. Driver, Mel J. Sharafuddin, Victoria Teodorescu, Bret N. Wiechmann, Charles S. Thompson, Larry W. Kraiss, Teresa L. Carman, Suhail Dohad, Paul P. Huang, Candice Junge, Kenneth Story, Tara Weistroffer, Tina Thorne, Meredith Millay, John Paul Runyon, Robert M. Schainfeld,

Biomedical Ethics and Regulation

Critical limb ischemia portends a risk of major amputation of 25% to 35% within 1 year of diagnosis. Preclinical studies provide evidence that intramuscular injection of autologous CD34+ cells improves limb perfusion and reduces amputation risk. In this randomized, double-blind, placebo-controlled pilot study, we evaluated the safety and efficacy of intramuscular injections of autologous CD34+ cells in subjects with moderate or high-risk critical limb ischemia, who were poor or noncandidates for surgical or percutaneous revascularization (ACT34-CLI).